Plug, Punctum

FDA product code LZU · Unclassified · Ophthalmic

49510(k) clearances
0PMA approvals
3recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K241229Hello,eyes® BIO PlugLZU · Traditional Bio Optics Co., Ltd.06/28/2024SE
K222164Visant Medical Canalicular PlugLZU · Traditional Visant Medical, Inc.12/23/2022SE
K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugLZU · Traditional Oasis Medical, Inc.06/03/2022SE
K190210Tear Pool Dissolvable Punctum PlugsLZU · Traditional Alphamed, Inc.10/24/2019SE
K162361Soft Plug Extended Duration 180 Canalicular PlugLZU · Traditional Oasis Medical, Inc.04/17/2017SE
K161673LacriPro Punctum PlugLZU · Traditional Lacrimedics, Inc.11/18/2016SE
K150288PDO Absorbable Punctum PlugLZU · Traditional Riverpoint Medical08/28/2015SE
K140352VeraplugLZU · Traditional Krishna Imports Inc Dba Stephens Instruments11/13/2014SE
K140711Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug…LZU · Traditional Paragon Bioteck, Inc.06/20/2014SE
K140026Collasyn Plug for the Lacrimal Efficiency TestLZU · Traditional Lacrimedics, Inc.06/03/2014SE
K090938Flow ControllerLZU · Traditional Odyssey Medical, Inc.06/04/2009SE
K061398Snug Plug Punctum PlugLZU · Traditional Fci Ophthalmics, Inc.07/11/2006SE
K053333Eaglevision Gellanserts, Model Ref 0040LZU · Traditional Eagle Vision, Inc.05/02/2006SE
K050851Delta Punctum PlugLZU · Traditional Delta Life Science, Inc.08/19/2005SE
K040912Hydrogel Canalicular PlugLZU · Traditional Partners IN Biomaterials, Inc.11/16/2004SE
K040231Inteliport Occluding DeviceLZU · Traditional Alcon, Inc.07/13/2004SE
K030300Opaque Herrick Lacrimal PlugLZU · Traditional Lacrimedics, Inc.05/09/2003SE
K022043Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503LZU · Traditional Medennium, Inc.10/18/2002SE
K021936Moist Punctal Plug SystemLZU · Traditional Moist Medical, Inc.10/16/2002SE
K020882Sharpoint Ultraplug Extended Wear PlugLZU · Traditional Surgical Specialties Corp07/26/2002SE
K021831Opaque Herrick Lacrimal Plug, 0.3MM,0.5MM,0.7MM, Models HLP3-OPB,HLP50OPB,HLP7-OPBLZU · Special Lacrimedics, Inc.07/01/2002SE
K013613Soft Plug Absorbable Plug-SaLZU · Traditional Oasis Medical, Inc.06/27/2002SE
K001768Occu-Flo Punctum PlugsLZU · Traditional U.S. Iol, Inc.09/19/2000SE
K001234Bioinsulated Silicone Punctum PlugLZU · Traditional Advanced Vision Science07/11/2000SE
K001737Opaque Herrick Plug, 0.3MM; 0.5MM; O.7MMLZU · Special Lacrimedics, Inc.06/19/2000SE
K991130FlexplugLZU · Special Eagle Vision, Inc.04/20/1999SE
K980844Surgidev Silicone Punctum PlugLZU · Traditional Advanced Vision Science05/11/1998SE
K980437Silicone Punctal PlugLZU · Traditional Oasis Medical, Inc.04/30/1998SE
K972523Punctual OccluderLZU · Traditional Odyssey Medical, Inc.09/09/1997SE
K970631Punctual OccluderLZU · Traditional Odyssey Medical, Inc.04/23/1997SE
K963708Herrick Ultimate Punctum PlugLZU · Traditional Lacrimedics, Inc.04/14/1997SE
K963501Herrick Ultimate Punctum PlugLZU · Traditional Lacrimedics, Inc.04/14/1997SE
K964774Punctum Plugs & Ready-Set Punctal PlugsLZU · Traditional Fci Ophthalmics, Inc.12/20/1996SE
K961909Ready-Set Punctal PlugsLZU · Traditional Fci Ophthalmics, Inc.07/25/1996SE
K953394Visitec Collar Button Catheter {Griffiths}LZU · Traditional Visitec Co.10/12/1995SE
K954094Ophta Sil- Punctal Plugs (Modification)LZU · Traditional G.W.B. Intl., Ltd.10/05/1995SE
K950569Ophta Sil {Self-Threading Monoka (Ritleng Type)}LZU · Traditional G.W.B. Intl., Ltd.03/14/1995SE
K946357Collagen Intracanalicular PlugLZU · Traditional Oasis Medical, Inc.02/07/1995SE
K945906Silicone Punctal PlugLZU · Traditional Oasis Medical, Inc.01/03/1995SE
K915809Visitec Canalicular StentLZU · Traditional Visitec Co.02/24/1992SE
K905427Eagle Vision Freeman Radiopague Punctum PlugLZU · Traditional Eagle Vision, Inc.06/06/1991SE
K911108Ophta Sil (R), Punctal Plugs and InsertersLZU · Traditional G.W.B. Intl., Ltd.05/13/1991SE
K905750Lacrimal PlugLZU · Traditional Tamcenan Corp.03/14/1991SE
K897190Look Temporary Intracanalicular Collagen ImplantLZU · Traditional Look, Inc.03/28/1990SE
K896175Herrick Lacrimal Plug Tm.LZU · Traditional Lacrimedics, Inc.01/22/1990SE
K895342Collagen Implants for the Lacrimal Efficiency TestLZU · Traditional Lacrimedics, Inc.11/02/1989SE
K890714Lacrimal Efficiency Test (TM)LZU · Traditional Lacrimedics, Inc.05/17/1989SE
K890919Temporary Intracanalicular Collagen ImplantLZU · Traditional Eagle Vision, Inc.05/16/1989SE
K890920Eagle Vision-Freeman(Tm) Punctal ValveLZU · Traditional Eagle Vision, Inc.04/11/1989SE

Recalls

RecallProductFirmInitiated
Z-0709-2022 Class IICollagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye…The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise… Lacrimedics Inc01/17/2022Open, Classified
Z-0708-2022 Class IIOPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx…The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise… Lacrimedics Inc01/17/2022Open, Classified
Z-1081-2015 Class IIIVisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn…Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The… Lacrimedics Inc11/26/2014Terminated