Unit, Phacofragmentation
FDA product code HQC · Class II (moderate risk) · 21 CFR 886.4670 · Ophthalmic
316510(k) clearances
0PMA approvals
71recalls
Manufacturers
- Storz Instrument Co. 17
- CooperVision, Inc. 15
- Chiron Vision Corp. 15
- Site Microsurgical Systems, Inc. 14
- Abbott Medical Optics, Inc. 9
- Bausch & Lomb, Inc. 9
- Surgin Surgical Instrumentation, Inc. 8
- Alcon Laboratories 8
- Ipax, Inc. 7
- Carl Zeiss Meditec Cataract Technology, Inc. 7
- Staar Surgical Co. 6
- American Optical Corp. 5
- American Surgical Company 5
- United Sonics, Inc. 5
- American Optisurgical, Inc. 5
- Medical Technical Products 5
- Medical Corp. of America 4
- Intl. Ophthalmic Industries Corp. 4
- Paradigm Medical Industries, Inc. 4
- Optical Micro Systems, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23…HQC · Special | Bausch and Lomb | 05/15/2026SE |
| K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…HQC · Traditional | Bausch and Lomb, Incorporated | 03/25/2026SE |
| K250501 | System SophiHQC · Traditional | This AG | 11/14/2025SE |
| K243395 | MICOR 700 with Auto I/AHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 08/08/2025SE |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 06/11/2025SE |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)HQC · Traditional | Bausch and Lomb, Incorporated | 07/26/2024SE |
| K233398 | Faros Surgical SystemHQC · Traditional | Oertli Instrumente AG | 06/27/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | Alcon Laboratories, Inc. | 06/21/2024SE |
| K232084 | Stellaris Elite vision enhancement systemHQC · Traditional | Bausch and Lomb | 02/26/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | Alcon Laboratories, Inc. | 01/10/2024SE |
| K230858 | Quatera 700HQC · Traditional | Carl Zeiss Meditec, AG | 07/31/2023SE |
| K214028 | MICOR Lens Fragmentation SystemHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 09/09/2022SE |
| K222236 | miCOR System Lens Fragmentation SystemHQC · Special | Carl Zeiss Meditec Cataract Technology, Inc. | 08/24/2022SE |
| K213467 | EVA NEXUS Ophthalmic Surgical SystemHQC · Traditional | D.O.R.C. Dutch Ophthalmic Research Center… | 06/14/2022SE |
| K212241 | Quatera 700HQC · Traditional | Carl Zeiss Meditec, AG | 04/19/2022SE |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced…HQC · Traditional | Johnson & Johnson Surgical Vision, Inc. | 03/12/2021SE |
| K200207 | xPORT S Lens Fragmentation SystemHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 10/15/2020SE |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation SystemHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 07/31/2020SE |
| K193376 | Visalis V500, Visalis S500HQC · Traditional | Carl Zeiss Meditec, AG | 06/15/2020SE |
| K192418 | Phacoemulsification Needle (Tip) and Irrigation SleeveHQC · Traditional | Raico, LLC | 05/27/2020SE |
| K191650 | LEGION SystemHQC · Traditional | Alcon Research, LLC | 11/01/2019SE |
| K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…HQC · Traditional | D.O.R.C. Dutch Ophthalmic Research Center… | 09/25/2019SE |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV…HQC · Special | Johnson & Johnson Surgical Vision, Inc. | 08/16/2019SE |
| K191024 | xPORT Lens Fragmentation SystemHQC · Traditional | Carl Zeiss Meditec Cataract Technology, Inc. | 08/13/2019SE |
| K170052 | Stellaris Elite vision enhancement systemHQC · Traditional | Bausch+Lomb | 04/19/2017SE |
| K161794 | CENTURION Vision System (Active SentryTM)HQC · Traditional | Alcon Research, Ltd. | 04/14/2017SE |
| K162342 | Stellaris Elite Vision Enhancement SystemHQC · Traditional | Bausch+Lomb | 03/24/2017SE |
| K160236 | Dual Pump PackHQC · Abbreviated | Abbott Medical Optics, Inc. | 04/27/2016SE |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…HQC · Traditional | Abbott Medical Optics, Inc. | 10/19/2015SE |
| K151783 | COMPACT INTUITIV Multiple-Use PackHQC · Abbreviated | Abbott Medical Optics, Inc. | 09/02/2015SE |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC…HQC · Traditional | Dutch Ophthalmic Research Center International BV | 03/13/2015SE |
| K133562 | Catarhex 3HQC · Traditional | Oertli Instrumente AG | 08/12/2014SE |
| K133486 | Stellaris PC Vision Enhancement SystemHQC · Traditional | Bausch & Lomb | 03/12/2014SE |
| K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…HQC · Abbreviated | Abbott Medical Optics, Inc. | 02/27/2014SE |
| K133242 | Stellaris Vision Enhancement SystemHQC · Special | Bausch & Lomb | 02/14/2014SE |
| K121555 | Centurion Vision SystemHQC · Traditional | Alcon Laboratories, Inc. | 12/21/2012SE |
| K122829 | Lensar Laser System - FS 3D for Corneal IncisionsHQC · Traditional | Lensar, Inc. | 12/03/2012SE |
| K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)HQC · Traditional | Abbott Medical Optics, Inc. | 10/15/2012SE |
| K120732 | Lenssx Laser SystemHQC · Traditional | Alcon Lensx, Inc. | 09/06/2012SE |
| K120912 | Infiniti(R) Vision SystemHQC · Traditional | Alcon Manufacturing, Ltd. | 06/15/2012SE |
| K111446 | Sovereign Compact Phacoemulsification SystemHQC · Traditional | Abbott Medical Optics, Inc. | 12/21/2011SE |
| K112425 | Infiniti Vision System Evergreen II Autosert Iol Injector HandpieceHQC · Traditional | Alcon Manufacturing, Ltd. | 11/21/2011SE |
| K111882 | Laminar Flow Phaco TipsHQC · Abbreviated | Abbott Medical Optics, Inc. | 11/07/2011SE |
| K111697 | Amo Whitestar Signature Phacoemulsification SystemHQC · Abbreviated | Abbott Medical Optics, Inc. | 09/27/2011SE |
| K103023 | Unit, PhacofragmentationHQC · Abbreviated | Abbott Medical Optics, Inc. | 06/01/2011SE |
| K101285 | Constellation Vision SystemHQC · Traditional | Alcon Manufacturing, Ltd. | 11/12/2010SE |
| K101325 | Stellaris PC Vision Enhancement SystemHQC · Traditional | Bausch & Lomb, Inc. | 08/17/2010SE |
| K093210 | Aqualase Capsule Wash TipHQC · Traditional | Alcon Manufacturing, Ltd. | 03/04/2010SE |
| K091915 | Fluid Isolation DeviceHQC · Traditional | Lenstec, Inc. | 10/27/2009SE |
| K091777 | Alcon UltrachopperHQC · Traditional | Alcon Research, Ltd. | 10/20/2009SE |
| K082845 | Infiniti Vision System with Ozil IpHQC · Traditional | Alcon Research, Ltd. | 02/12/2009SE |
| K082473 | Bausch & Lomb Stellaris Microsurgical SystemHQC · Abbreviated | Bausch & Lomb, Inc. | 01/05/2009SE |
| K081877 | Associate 2500 Dual and Compact SystemsHQC · Traditional | Dutch Ophthalmic Research Center International BV | 01/05/2009SE |
| K080803 | Visual Phacoemulsification System, Model 551HQC · Traditional | American Optisurgical, Inc. | 09/22/2008SE |
| K082132 | Bausch & Lomb D4600A Air Exchange Line PackHQC · Special | Bausch & Lomb, Inc. | 08/28/2008SE |
| K063583 | Alcon Vision SystemHQC · Traditional | Alcon | 05/09/2008SE |
| K073023 | Sterils Single-Use I/A HandpiecesHQC · Special | Bausch & Lomb, Inc. | 03/12/2008SE |
| K063331 | Bausch & Lomb NGX Microsurgical SystemHQC · Abbreviated | Bausch & Lomb, Inc. | 12/19/2006SE |
| K060366 | The Amo Ophthalmic Surgical SystemHQC · Abbreviated | Advanced Medical Optics, Inc. | 04/07/2006SE |
| K051186 | Micropulse Phacoemulsification SystemHQC · Abbreviated | Trillium Medical, Inc. | 08/18/2005SE |
| K050648 | Sovereign High Vacuum Pack, Sovereign Compact High Vacuum PackHQC · Traditional | Advanced Medical Optics, Inc. | 04/05/2005SE |
| K041998 | Phaco Chop NeedlesHQC · Special | Bausch & Lomb, Inc. | 08/16/2004SE |
| K033653 | Venturi Phaco PackHQC · Special | Bausch & Lomb, Inc. | 12/17/2003SE |
| K030957 | Perfect CapsuleHQC · Traditional | Milvella Pty. , Ltd. | 08/20/2003SE |
| K031404 | Dignity Ophthalmic Surgical SystemHQC · Traditional | Phacor Inc., A Santen Company | 05/22/2003SE |
| K022833 | Benjamin Envoy Phaco HandpieceHQC · Traditional | Benjamin Biomedical, Inc. | 09/09/2002SE |
| K020527 | Horizon Phacoemulsification System, Model HZN-2030HQC · Traditional | American Optisurgical, Inc. | 07/09/2002SE |
| K021566 | InfinitiHQC · Traditional | Alcon Laboratories, Inc. | 07/02/2002SE |
| K020734 | Surge-Free Aspiration AdapterHQC · Traditional | Staar Surgical Co. | 05/16/2002SE |
| K003638 | Mojave Cataract Extraction SystemHQC · Abbreviated | Allergan, Inc. | 02/13/2001SE |
| K003512 | Laser Pack I, Laser Pack II, Phaco Pack I, Phaco Pack IIHQC · Traditional | A.R.C. Laser AG | 02/08/2001SE |
| K002932 | PhacogardHQC · Traditional | Syntec, Inc. | 01/04/2001SE |
| K002031 | Phacofragmentation System MegatronHQC · Traditional | Asclepion-Meditec AG | 12/27/2000SE |
| K002986 | A.R.C. Low Bubble Turbo Needle, Model WE0106.5HQC · Traditional | A.R.C. Laser AG | 11/29/2000SE |
| K002812 | Iris Retracting Phacoemulsification SleeveHQC · Traditional | Michael Reynard, M.D. | 11/08/2000SE |
| K991852 | Ocusystem Art Advantage, Model 995HQC · Traditional | Surgical Design Corp. | 07/07/1999SE |
| K984143 | Fibra-Sonics Phaco III or Iiip Fragmentation SystemHQC · Traditional | Fibra Sonics, Inc. | 02/16/1999SE |
| K981989 | The Wave Digital Phaco SystemHQC · Traditional | Circuit Tree | 08/25/1998SE |
| K981103 | Turbosonics Limited Reuse Ultrasonic TipHQC · Traditional | Alcon Laboratories | 06/23/1998SE |
| K981109 | QuitetipHQC · Traditional | Paradigm Medical Industries, Inc. | 06/09/1998SE |
| K980480 | Syntec VitmanHQC · Traditional | Syntec, Inc. | 05/04/1998SE |
| K980085 | Phaco CommanderHQC · Traditional | Scieran Technologies, Inc. | 02/24/1998SE |
| K974469 | Mentor Phacoemulsification Sistem Remote ControlHQC · Traditional | Mentor Corp. | 02/24/1998SE |
| K974719 | PhacopakHQC · Traditional | Paradigm Medical Industries, Inc. | 01/20/1998SE |
| K973749 | Frag CommanderHQC · Traditional | Scieran Technologies, Inc. | 12/08/1997SE |
| K972063 | Whittingham Ultraclean Phaco HandpieceHQC · Traditional | William F. Whittingham | 11/25/1997SE |
| K972253 | P3 Universal Phaco HandpieceHQC · Traditional | Odyssey Technologies, Inc. | 07/29/1997SE |
| K972252 | Vista Universal HandpieceHQC · Traditional | Odyssey Technologies, Inc. | 07/29/1997SE |
| K971795 | Automated Chamber Maintenance ModuleHQC · Traditional | Paradigm Medical Industries, Inc. | 07/14/1997SE |
| K971750 | Welch Allyn Phaco IlluminatorHQC · Traditional | Welch Allyn, Inc. | 06/30/1997SE |
| K971439 | Storz Microflow and Storz Standard Phacoemulsification NeedlesHQC · Traditional | Storz Instrument Co. | 06/17/1997SE |
| K971186 | Amo Diplomax/Opsys ConsoleHQC · Traditional | Allergan, Inc. | 06/13/1997SE |
| K971064 | Bayers Bimanual I/A HandpiecesHQC · Traditional | Visioncare Devices, Inc. | 06/09/1997SE |
| K965127 | DGH Model 9000HQC · Traditional | Dgh Technology, Inc. | 03/17/1997SE |
| K964018 | Phacoilluminator - Fiberoptic SleeveHQC · Traditional | Michael Reynard, M.D. | 02/26/1997SE |
| K960287 | Handpiece for Nidek CV-12000 Phaco SystemHQC · Traditional | Nidek, Inc. | 11/05/1996SE |
| K960811 | PhacoscopeHQC · Traditional | Saint John'S Plaza Medical Group | 10/02/1996SE |
| K960024 | Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle WrenchHQC · Traditional | Storz Instrument Co. | 09/20/1996SE |
| K962402 | Amo Prestige Day Pack (Allergan, Inc.)HQC · Traditional | Allergan, Inc. | 09/19/1996SE |
| K960003 | Storz D7116 Microvit Vitrectomy Cutter ExtensionHQC · Traditional | Storz Instrument Co. | 08/29/1996SE |
| K962131 | Storz D4600 Air Exchange Line PackHQC · Traditional | Storz Instrument Co. | 08/23/1996SE |
| K961874 | Storz DP5100 Anterior Collection Cassette PackHQC · Traditional | Storz Instrument Co. | 08/06/1996SE |
| K961831 | Storz DP5200 Irrigation Addministration Set PackHQC · Traditional | Storz Instrument Co. | 08/06/1996SE |
| K961820 | Storz DP4600 Anterior Intraocular Pressure Control PackHQC · Traditional | Storz Instrument Co. | 07/25/1996SE |
| K962431 | CTM Disposable PakHQC · Traditional | Circuit Tree Medical, Inc. | 07/23/1996SE |
| K962430 | CTM Reusable PakHQC · Traditional | Circuit Tree Medical, Inc. | 07/23/1996SE |
| K961658 | Megatron Ophthalmic Surgical SystemHQC · Traditional | Intl. Ophthalmic Industries Corp. | 07/23/1996SE |
| K961243 | Ocusystem Art AdvantageHQC · Traditional | Surgical Design Corp. | 07/10/1996SE |
| K961310 | Storz Premiere II Microsurgical System (CX Series)HQC · Traditional | Storz Instrument Co. | 06/27/1996SE |
| K960414 | Synergist Power PackHQC · Traditional | Chiron Vision Corp. | 04/24/1996SE |
| K955901 | Storz DP4310DELUXE Phaco Pack Without RefluxHQC · Traditional | Storz Instrument Co. | 03/28/1996SE |
| K955789 | Alcon Series 20000 Legacy Mackool SystemHQC · Traditional | Alcon Laboratories | 03/21/1996SE |
| K955245 | Mentor Meridian Phacoemulsification SystemHQC · Traditional | Mentor O & O, Inc. | 02/12/1996SE |
| K954746 | Phaco TipHQC · Traditional | U.S. Iol, Inc. | 01/11/1996SE |
| K953539 | DM001 Disposable PackHQC · Traditional | American Optisurgical, Inc. | 12/26/1995SE |
| K953538 | RM001 ReusableHQC · Traditional | American Optisurgical, Inc. | 12/26/1995SE |
| K954340 | Storz Microflow Phacoemulsification NeedleHQC · Traditional | Storz | 12/14/1995SE |
| K954239 | U.S. Iol Phaco HandpieceHQC · Traditional | U.S. Iol, Inc. | 12/08/1995SE |
| K954238 | Surgin Genisis HandpieceHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 12/08/1995SE |
| K954237 | Circuit Tree Phaco HandpieceHQC · Traditional | Circuit Tree | 12/08/1995SE |
| K954242 | Circuit Tree PhacoemulsifierHQC · Traditional | Circuit Tree | 12/01/1995SE |
| K954241 | Surgin Genisis PhacoemulsifierHQC · Traditional | Surgeon Surgical Instrumentation, Inc. | 12/01/1995SE |
| K954240 | Evolution PhacomulsifierHQC · Traditional | U.S. Iol, Inc. | 12/01/1995SE |
| K953959 | Phaco Handpiece for Phaco Fragmentation Machines, Phaco Sleeve for Attachment to Phaco…HQC · Traditional | Microsurgical Technology, Inc. | 11/17/1995SE |
| K951463 | Storz I/A HandpiecesHQC · Traditional | Storz Instrument Co. | 10/27/1995SE |
| K953359 | Tri-Star Universal I/A Phaco PakHQC · Traditional | Tri-Star Ophthalmic | 10/17/1995SE |
| K953447 | Precisionist Thirty ThousandHQC · Traditional | Paradigm Medical Industries, Inc. | 10/13/1995SE |
| K944993 | Iolab.Site CD Phacoemulsification ModuleHQC · Traditional | Chiron Vision Corp. | 10/12/1995SE |
| K944995 | Iolab/Site Peristaltic ModuleHQC · Traditional | Chiron Vision Corp. | 10/05/1995SE |
| K950881 | Phaco TipHQC · Traditional | American Optical Corp. | 09/06/1995SE |
| K952468 | Hi-Line Medical Phacoemulsifier TipHQC · Traditional | Hi-Line Medical | 08/24/1995SE |
| K952331 | Aoi LC-40 PhacoemulsifierHQC · Traditional | American Optisurgical, Inc. | 08/16/1995SE |
| K952213 | Alcon Series 20000 Legacy PhacoemulsifierHQC · Traditional | Alcon Laboratories | 08/09/1995SE |
| K953078 | Storz DP4101 Basic I/A PackHQC · Traditional | Storz Instrument Co. | 08/07/1995SE |
| K951824 | Storz Microseal Phacoemulsification Needles (Importation)HQC · Traditional | Nidek, Inc. | 07/19/1995SE |
| K950218 | Oms Slimline Phaco HandpieceHQC · Traditional | Optical Micro Systems, Inc. | 07/17/1995SE |
| K946054 | DiplomaxHQC · Traditional | Optical Micro Systems, Inc. | 07/11/1995SE |
| K951462 | Amo Profinesse III Ultrasonic Handpiece SystemHQC · Traditional | Allergan Medical Optics | 06/15/1995SE |
| K952259 | Storz Microseal DP8030 & DP8045 Phacoemulsification NeedlesHQC · Traditional | Storz Instrument Co. | 06/14/1995SE |
| K950114 | Stotz Protege(Tm) Microsurgical SystemHQC · Traditional | Storz Instrument Co. | 06/02/1995SE |
| K950880 | Aoi Universal Ultrasonic HandpieceHQC · Traditional | American Optical Corp. | 05/26/1995SE |
| K950800 | Pro-Pak for Oms DiplomateHQC · Traditional | M. Imonti and Associates Inc., | 05/22/1995SE |
| K950798 | Posterior Capsule ShieldHQC · Traditional | Oasis Medical, Inc. | 05/22/1995SE |
| K950600 | Vacuum Surge SupresserHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 05/10/1995SE |
| K946227 | Storz Premiere(R) Microsurgical SystemHQC · Traditional | Storz Instrument Co. | 03/22/1995SE |
| K944994 | Iolab/Site Disposable Diaphragm CassetteHQC · Traditional | Chiron Vision Corp. | 03/14/1995SE |
| K946176 | Storz Phacoemulsification NeedlesHQC · Traditional | Storz Instrument Co. | 02/14/1995SE |
| K945583 | Ocusystem(Art)HQC · Traditional | Arent Fox | 02/13/1995SE |
| K942945 | Cassette System for StorzHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 12/05/1994SE |
| K935926 | Storz Phaco and Frag HandpiecesHQC · Traditional | Storz Instrument Co. | 11/28/1994SE |
| K943672 | Phaco Needles and TipsHQC · Traditional | Microsurgical Technology, Inc. | 10/13/1994SE |
| K943379 | Phaco Tips for Phaco Fragmentation MachinesHQC · Traditional | Oasis Medical, Inc. | 10/11/1994SE |
| K940083 | Standard Phaco Tip 15, 30, 45, 60HQC · Traditional | Medical Technical Products | 09/28/1994SE |
| K940088 | Medical Technical Products Standard Ultrasonic HandpieceHQC · Traditional | Medical Technical Products | 08/04/1994SE |
| K943102 | High Performance TipsHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 07/28/1994SE |
| K942518 | Cassette System for SiteHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 07/25/1994SE |
| K942517 | 10-K CassetteHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 07/25/1994SE |
| K942516 | 10-0 CassetteHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 07/25/1994SE |
| K942515 | Phaco KitHQC · Traditional | Surgin Surgical Instrumentation, Inc. | 07/25/1994SE |
| K940084 | Model 2000 Ophthalmic Surgical SystemHQC · Traditional | Medical Technical Products | 06/17/1994SE |
| K923630 | Phaco Needles 1000-R & 1000-O NeedlesHQC · Traditional | O.R. Specialties, Inc. | 04/06/1994SE |
| K935223 | Ophthalmic Surgical SystemHQC · Traditional | Optical Micro Systems, Inc. | 03/14/1994SE |
| K931358 | AORP4000 Reusable PakHQC · Traditional | American Optical Corp. | 02/22/1994SE |
| K931354 | P4000 PhacoemulsifierHQC · Traditional | American Optical Corp. | 02/22/1994SE |
| K925828 | Modified Site TXR SystemsHQC · Traditional | Site Microsurgical Systems, Inc. | 02/16/1994SE |
| K933627 | Phacofragmentor TipHQC · Traditional | M. Imonti and Associates Inc., | 01/25/1994SE |
| K931357 | AOD4000 Disposable PakHQC · Traditional | American Optical Corp. | 01/25/1994SE |
| K933503 | Pro-Phaco HandpieceHQC · Traditional | M. Imonti and Associates Inc., | 01/06/1994SE |
| K926381 | Ocusystem IieHQC · Traditional | Surgeon Design | 12/06/1993SE |
| K931866 | Site's CD II Phacoemulsification HandpieceHQC · Traditional | Site Microsurgical Systems, Inc. | 11/12/1993SE |
| K926512 | Storz Modified Phaco Needle with Insulation SleeveHQC · Traditional | Storz | 09/09/1993SE |
| K925631 | Phacotron Gold Multifunction Ultrasonic HandpieceHQC · Traditional | Chiron Intraoptics | 07/29/1993SE |
| K924260 | Nidek CV-12000HQC · Traditional | Nidek, Inc. | 03/26/1993SE |
| K923725 | Ophthalmic Pharco NeedleHQC · Traditional | Synergetics, Inc. | 03/18/1993SE |
| K925254 | Amo(R) Flrx-Tip(Tm) Dispos I/A Handpiece, OPO-38HQC · Traditional | Allergan Medical Optics | 01/07/1993SE |
| K924235 | Amo EliteHQC · Traditional | Allergan Medical Optics | 12/23/1992SE |
| K924033 | Altex Model UST-3000EHQC · Traditional | Optro-Mechanics (Usa) Corp. | 11/05/1992SE |
| K922595 | Modified Site Macrobore Phaco NeedleHQC · Traditional | Chiron Vision Corp. | 08/31/1992SE |
| K921607 | Iolab Reusable Peristatic Cassette/Ophthalmic UseHQC · Traditional | Chiron Vision Corp. | 06/30/1992SE |
| K912904 | Mentor Odyssey Phacoemulsification SystemHQC · Traditional | Mentor O & O, Inc. | 06/11/1992SE |
| K921135 | Iolab Power I.V. PoleHQC · Traditional | Site Microsurgical Systems, Inc. | 06/03/1992SE |
| K915457 | Phaco 20/20 System IHQC · Traditional | Innovative Medical Systems, Inc. | 02/24/1992SE |
| K915456 | Phaco 3000 LinearHQC · Traditional | Innovative Medical Systems, Inc. | 02/12/1992SE |
| K915118 | Phaco Emulsification,Irrigation/Aspiration TubeHQC · Traditional | Ipax, Inc. | 12/27/1991SE |
| K914229 | Phaco TipHQC · Traditional | Tri-Star Ophthalmic | 12/27/1991SE |
| K912902 | Phacoemulsification System for Ophthalmic UseHQC · Traditional | Site Microsurgical Systems, Inc. | 12/17/1991SE |
| K914172 | Kpe 230 AmHQC · Traditional | Ipax, Inc. | 10/25/1991SE |
| K913530 | Look ViscodissectorHQC · Traditional | Look, Inc. | 10/21/1991SE |
| K912739 | Site 90 Tip, I/A Handpiece .3MM Side Open/Opth UseHQC · Traditional | Site Microsurgical Systems, Inc. | 08/28/1991SE |
| K911808 | Gemini Ophthalmic Surgery SystemHQC · Traditional | Alcon Laboratories | 06/25/1991SE |
| K904612 | I/A-Phaco System (Irr./Aspir./And Phaco./System)HQC · Traditional | Medical Technical Products | 12/26/1990SE |
| K904183 | Site Phacoemulsification HandpieceHQC · Traditional | Site Microsurgical Systems, Inc. | 12/05/1990SE |
| K904151 | Site 19 Gauge Ultrasonic I/A Phaco NeedleHQC · Traditional | Site Microsurgical Systems, Inc. | 12/05/1990SE |
| K902876 | Phacotron Systems Plus III Phacoemulsifier Aspi.HQC · Traditional | Intraoptics Surgical, Inc. | 09/18/1990SE |
| K902798 | Automated Hydrosonics(Tm)HQC · Traditional | Alcon Surgical, Inc. | 08/28/1990SE |
| K900493 | The PrecisionistHQC · Traditional | Paradigm Medical, Inc. | 08/28/1990SE |
| K902150 | Piezo HandpieceHQC · Traditional | United Surgical Corp. | 07/05/1990SE |
| K901686 | Nidek/Phaco Emulsification System Model CV-8000HQC · Traditional | Nidek, Inc. | 06/08/1990SE |
| K894512 | Phacoemulsification Unit to Remove Catarac. LensHQC · Traditional | Intl. Ophthalmic Industries Corp. | 10/17/1989SE |
| K894511 | Magnetron Munich Model Electronic Control UnitHQC · Traditional | Intl. Ophthalmic Industries Corp. | 10/17/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0305-2026 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and…Due to incomplete seals in the pouch which provide the sterile barrier. | Alcon Research LLC | 08/05/2025Open, Classified |
| Z-2109-2025 Class II | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined…Due to the potential that some units within specific lots were damaged during the manufacturing process. The… | Alcon Research LLC | 04/28/2025Open, Classified |
| Z-2680-2024 Class II | Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2679-2024 Class II | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2678-2024 Class II | Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2677-2024 Class II | Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2676-2024 Class II | Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2675-2024 Class II | Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2674-2024 Class II | Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2673-2024 Class II | Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2672-2024 Class II | Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2671-2024 Class II | Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2647-2024 Class II | Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-2646-2024 Class II | Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software…Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel… | Alcon Research LLC | 07/15/2024Open, Classified |
| Z-1755-2024 Class II | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber…Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this… | Johnson & Johnson Surgical Vision, Inc. | 03/14/2024Open, Classified |
| Z-1333-2024 Class II | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)When using those products you may experience difficulties to extend or retract the laser fiber, and in some… | D.O.R.C. Dutch Opthalmic Research Center… | 01/15/2024Open, Classified |
| Z-1332-2024 Class II | Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)When using those products you may experience difficulties to extend or retract the laser fiber, and in some… | D.O.R.C. Dutch Opthalmic Research Center… | 01/15/2024Open, Classified |
| Z-1331-2024 Class II | Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)When using those products you may experience difficulties to extend or retract the laser fiber, and in some… | D.O.R.C. Dutch Opthalmic Research Center… | 01/15/2024Open, Classified |
| Z-0099-2024 Class II | Constellation Vision System, REF: 8065751150Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to… | Alcon Research, LLC | 08/18/2023Open, Classified |
| Z-2411-2023 Class II | Alcon Custom PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | Alcon Research, LTD. | 06/28/2023Open, Classified |
| Z-2410-2023 Class II | Phaco Standalone TipsReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | Alcon Research, LTD. | 06/28/2023Open, Classified |
| Z-2409-2023 Class II | Legion FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | Alcon Research, LTD. | 06/28/2023Open, Classified |
| Z-2408-2023 Class II | Infinity FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | Alcon Research, LTD. | 06/28/2023Open, Classified |
| Z-2407-2023 Class II | Centurion FMS PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | Alcon Research, LTD. | 06/28/2023Open, Classified |
| Z-2406-2023 Class II | Constellation Procedure PakReports of patient injury during use in procedures due to potential for plastic debris from over-tightening… | Alcon Research, LTD. | 06/28/2023Open, Classified |
| Z-2247-2023 Class II | VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a… | Johnson & Johnson Surgical Vision, Inc. | 05/30/2023Open, Classified |
| Z-1007-2023 Class II | Single-Use Packs, REF: OPO80Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification… | Johnson & Johnson Surgical Vision, Inc. | 12/07/2022Open, Classified |
| Z-1006-2023 Class II | FUSION Dual Pump Packs, REF: OPO73Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification… | Johnson & Johnson Surgical Vision, Inc. | 12/07/2022Open, Classified |
| Z-1005-2023 Class II | Veritas Advanced Infusion Packs, REF: VRT-AIWeld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification… | Johnson & Johnson Surgical Vision, Inc. | 12/07/2022Open, Classified |
| Z-0086-2023 Class II | Veritas Advanced Infusion Packs. Used in ophthalmic procedures.As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation… | Johnson & Johnson Surgical Vision, Inc. | 09/01/2022Open, Classified |
| Z-1033-2022 Class II | TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,Potential breach in the sterility barrier for tray ring covers. | Johnson & Johnson Surgical Vision Inc | 04/06/2022Open, Classified |
| Z-2252-2021 Class II | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled…Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | Dutch Ophthalmic USA, Inc. | 05/21/2019Open, Classified |
| Z-1794-2020 Class II | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product…There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a… | Alcon Research LLC | 07/25/2018Terminated |
| Z-0779-2018 Class II | Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.)…Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS… | Alcon Research, LTD. | 01/12/2018Terminated |
| Z-0778-2018 Class II | Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy…Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS… | Alcon Research, LTD. | 01/12/2018Terminated |
| Z-2834-2016 Class II | LAUREATE World Phaco SystemSteps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) | Alcon Research, Ltd. | 07/28/2016Terminated |
| Z-2081-2016 Class II | CENTURION Vision SystemThe grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC… | Alcon Research, Ltd. | 05/24/2016Terminated |
| Z-1940-2016 Class II | CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and…Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due… | Alcon Research, Ltd. | 04/28/2016Terminated |
| Z-1940-2015 Class II | Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous…Insufficient seal on the outside packaging, potentially affecting the sterility of the product. | Alcon Research, Ltd. | 06/02/2015Terminated |
| Z-0506-2015 Class II | INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE.…Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in the… | Alcon Research, Ltd. | 10/30/2014Terminated |
| Z-1597-2016 Class II | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718…The recalling firm received complaints related to leakage from the tubing near the white luer of the… | Alcon Research, Ltd. | 10/06/2014Terminated |
| Z-1670-2013 Class II | Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system…Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory… | Abbott Medical Optics, Inc. | 05/23/2013Terminated |
| Z-0593-2013 Class II | Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM).…Posterior fluidics modules installed in the system may need to be recalibrated. | Bausch & Lomb Inc | 08/31/2012Terminated |
| Z-3090-2011 | Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114…The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | Bausch & Lomb Inc | 07/27/2011Terminated |
| Z-3089-2011 | Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6…The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | Bausch & Lomb Inc | 07/27/2011Terminated |
| Z-3088-2011 | Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX…The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | Bausch & Lomb Inc | 07/27/2011Terminated |
| Z-3087-2011 | Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case…The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | Bausch & Lomb Inc | 07/27/2011Terminated |
| Z-1934-2010 | Constellation Vision System, Model: Constellation T, Catalogue Number: 8065751558 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | Alcon Research LTD dba Alcon Laboratories… | 04/30/2010Terminated |
| Z-1933-2010 | Constellation Vision System, Model: Constellation L, Catalogue Number: 8065751554 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | Alcon Research LTD dba Alcon Laboratories… | 04/30/2010Terminated |
| Z-1932-2010 | Constellation Vision System, Model: Constellation X, Catalogue Number: 8065751553 The…Alcon identified system performance and machine settings that may impact the infusion performance of the… | Alcon Research LTD dba Alcon Laboratories… | 04/30/2010Terminated |