Lens, Guide, Intraocular
FDA product code KYB · Class I (low risk) · 21 CFR 886.4300 · Ophthalmic
39510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Staar Surgical Co. 7
- Alcon Laboratories 3
- Duckworth & Kent, Ltd. 2
- Allergan Medical Optics 2
- Chiron Ophthalmics 2
- Chiron Vision Corp. 2
- CooperVision, Inc. 2
- Microtech, Inc. 1
- Allergan, Inc. 1
- Bova Intl. 1
- Staar Sugical 1
- Coopervision-Cilco 1
- Depuy, Inc. 1
- Intermedics Intraocular, Inc. 1
- Innovative Surgical Products, Inc. 1
- Precision-Cosmet Co., Inc. 1
- I For M, Inc. 1
- American Medical Optics 1
- Cilco, Inc. 1
- Biomet, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152357 | MicroSTAAR Injector System CartridgesKYB · Special | STAAR Surgical Company | 10/30/2015SE |
| K081382 | Duckworth & Kent, Ltd., Implantation System, Model DK7786KYB · Traditional | Duckworth & Kent, Ltd. | 10/23/2008SE |
| K072985 | Duckworth & Kent Ltd Injector, Model: DK7797-2KYB · Traditional | Duckworth & Kent, Ltd. | 06/20/2008SE |
| K070669 | Iol Injector SetKYB · Traditional | Medicel AG | 11/01/2007SE |
| K063155 | Monarch III Iol Delivery SystemKYB · Traditional | Alcon Manufacturing, Ltd. | 03/27/2007SE |
| K063694 | Akreos Single Use Insertion Device, Model AI-28KYB · Special | Bausch & Lomb, Inc. | 03/07/2007SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | Staar Surgical Co. | 06/10/2004SE |
| K022723 | Mastel 1 Folder Implantation SystemKYB · Traditional | Mastel Precision, Inc. | 12/26/2002SE |
| K001157 | Monarch II Iol Delivery SystemKYB · Traditional | Alcon Research, Ltd. | 06/27/2000SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | Staar Surgical Co. | 12/04/1998SE |
| K981571 | Monarch Iol Delivery SystemKYB · Traditional | Alcon Laboratories | 07/09/1998SE |
| K970033 | Monarch Iol Delivery SystemKYB · Traditional | Alcon Laboratories | 04/23/1997SE |
| K965185 | Acrypak FolderKYB · Traditional | Alcon Laboratories | 03/31/1997SE |
| K961242 | Amo Phacoflex II Intersection SystemKYB · Traditional | Allergan, Inc. | 06/17/1996SE |
| K954600 | Microstaar Injector Models Msi-Td & Msi-Pd (Modification)KYB · Traditional | Staar Surgical Co. | 12/21/1995SE |
| K951292 | Passport Foldable Lens Placement SystemKYB · Traditional | Chiron Vision Corp. | 06/02/1995SE |
| K930628 | Klaas Iol LensfolderKYB · Traditional | Bova Intl. | 02/07/1995SE |
| K940593 | Disposable Microstaar InjectorKYB · Traditional | Staar Sugical | 09/19/1994SE |
| K941603 | Amo Phacoflex Inserter Disposable Cartridge, and HandpieceKYB · Traditional | Allergan Medical Optics | 07/06/1994SE |
| K930320 | Amo Phacoflex Inserter, Foldable Iol Insert InstrKYB · Traditional | Allergan Medical Optics | 04/07/1994SE |
| K903575 | Chiroflex ForcepsKYB · Traditional | Chiron Ophthalmics | 12/21/1990SE |
| K903574 | Chiroflex Lens MicrosertKYB · Traditional | Chiron Ophthalmics | 09/17/1990SE |
| K883489 | Kratz Nova Sert(Tm)KYB · Traditional | Coopervision-Cilco | 10/25/1988SE |
| K871440 | Kratz Nova-SertKYB · Traditional | CooperVision, Inc. | 05/07/1987SE |
| K870265 | Kratz Nova-Sert. Soft Intraocular Lens InjectorKYB · Traditional | CooperVision, Inc. | 02/20/1987SE |
| K861990 | Soft Lens FolderKYB · Traditional | Staar Surgical Co. | 06/17/1986SE |
| K861085 | Elastic Lens Injector TMKYB · Traditional | Staar Surgical Co. | 05/28/1986SE |
| K860148 | Mazzocco/Frenchik FolderKYB · Traditional | Staar Surgical Co. | 03/21/1986SE |
| K854994 | Bartell Small Incision Lens GlideKYB · Traditional | Microtech, Inc. | 02/04/1986SE |
| K854197 | Iosert Lens Implant InstrumentKYB · Traditional | Chiron Vision Corp. | 01/22/1986SE |
| K841730 | Bailey Lens ShooterKYB · Traditional | Intermedics Intraocular, Inc. | 11/19/1984SE |
| K840694 | Lens Insertion GlideKYB · Traditional | Innovative Surgical Products, Inc. | 05/09/1984SE |
| K840104 | Petrus Iol GuideKYB · Traditional | Precision-Cosmet Co., Inc. | 04/24/1984SE |
| K832939 | I-Glide Iol Implantation AidKYB · Traditional | I For M, Inc. | 10/04/1983SE |
| K823222 | Intraocular Lens GuideKYB · Traditional | American Medical Optics | 12/28/1982SE |
| K821381 | Iol ForcepsKYB · Traditional | Cilco, Inc. | 06/14/1982SE |
| K811718 | Surface Replacement Hip ProsthesisKYB · Traditional | Biomet, Inc. | 09/18/1981SE |
| K792066 | M.P.I. Lens GlideKYB · Traditional | J. Leon Bilby | 01/29/1980SE |
| K791351 | Cement SpacersKYB · Traditional | Depuy, Inc. | 08/03/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0835-2025 Class II | Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number:…Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which… | Alcon Research LLC | 11/13/2024Open, Classified |
| Z-1964-2016 Class II | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular… | Staar Surgical Co. | 05/02/2016Terminated |
| Z-1673-2009 | Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal…Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the… | Volk Optical Inc | 01/23/2009Terminated |
| Z-2441-2008 | MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in…Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion… | Alcon Laboratories, Inc | 07/07/2008Terminated |