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Bausch & Lomb, Inc.

64 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedur recall (Z-0983-2017)Bausch & Lomb, Inc.2017-01-10
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb In recall (Z-0862-2015)Bausch & Lomb Inc2014-12-23
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL227 recall (Z-0863-2015)Bausch & Lomb Inc2014-12-23
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL22 recall (Z-0864-2015)Bausch & Lomb Inc2014-12-23
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The recall (Z-0593-2013)Bausch & Lomb Inc2012-12-20
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, recall (Z-3087-2011)Bausch & Lomb Inc2011-08-30
Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, S recall (Z-3088-2011)Bausch & Lomb Inc2011-08-30
Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/cas recall (Z-3089-2011)Bausch & Lomb Inc2011-08-30
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, pac recall (Z-3090-2011)Bausch & Lomb Inc2011-08-30
Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distri recall (Z-3042-2011)Bausch & Lomb Inc2011-08-19
Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufacture recall (Z-1025-2011)Bausch & Lomb Inc2011-02-02
Up&Up Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Ta recall (Z-1026-2011)Bausch & Lomb Inc2011-02-02
Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box recall (Z-1708-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and DP4310E, 6 packs/box recall (Z-1709-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Millennium Advanced Flow System Phaco Pack, Model CX5310, 6 packs/box, RX, S recall (Z-1710-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Millennium Micro Incision Premium Venturi Pack, Model CX4320, 6 packs/box, R recall (Z-1711-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. recall (Z-1712-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris Vacuum Phaco Pack, Model BL5111, 6 packs/box, RX, Sterile. The fir recall (Z-1713-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Model BL5112, 6 packs/box, RX, St recall (Z-1714-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile. Th recall (Z-1715-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The recall (Z-1716-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Needle, Model BL5113, 6 p recall (Z-1717-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris 1.8mm StableChamber Phaco Pack with MICS Angled Needle, Model BL51 recall (Z-1718-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Model BL5114, 6 recall (Z-1719-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle, Model BL5 recall (Z-1720-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Needle, Model BL5123 recall (Z-1721-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Stellaris 1.8mm Micro Incision AFS Phaco Pack with MICS Angled Needle, Model recall (Z-1722-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb 19G Standard 30 Phaco Needle, Model DP8130S, 6 pouches/box. The firm name on recall (Z-1723-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb 19G Standard 45 Phaco Needle, Model DP8145S, 6 pouches per box. The firm nam recall (Z-1724-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb MicroFlow 30 Phaco Needle, Model DP8230S, 6 pouches/box. The firm name on th recall (Z-1725-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb MicroFlow 45 Phaco Needle, Model DP8245S, 6 pouches/box. The firm name on th recall (Z-1726-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb MicroFlow Plus 30 Phaco Needle, Model DP8330S, 6 pouches/box. The firm name recall (Z-1727-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Thin Tip 30 Phaco Needle, Model DP8430S, 6 pouches/box. The firm name on the recall (Z-1728-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Thin Tip 30 angled Phaco Needle, Model DP8430AS, 6 pouches/box. The firm nam recall (Z-1729-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb MicroFlow 2.2 30 Phaco Needle, Model DP8730S, 6 pouches/box. The firm name o recall (Z-1730-2010)Bausch & Lomb Inc2010-05-28
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigi recall (Z-1705-2010)Bausch & Lomb Inc2010-05-27
Bausch & Lomb Millennium Microsurgical System. recall (Z-1663-2010)Bausch & Lomb Inc2010-05-26
Bausch & Lomb Stellaris Vision Enhancement System. recall (Z-1664-2010)Bausch & Lomb Inc2010-05-26
Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufact recall (Z-0591-2010)Bausch & Lomb Inc2010-01-11
Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, recall (Z-0553-2010)Bausch & Lomb Inc2009-12-22
Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated recall (Z-0159-2010)Bausch & Lomb Inc2009-11-10
Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. recall (Z-1911-2009)Bausch & Lomb Inc2009-09-09
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Con recall (Z-1735-2009)Bausch & Lomb Inc2009-08-13
Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufa recall (Z-0103-2009)Bausch & Lomb Inc2008-10-22
Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one o recall (Z-0104-2009)Bausch & Lomb Inc2008-10-22
Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15 Degree, REF DP recall (Z-2044-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8 recall (Z-2045-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 45 Degree, REF DP8 recall (Z-2046-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 15 Degree, REF DP8415 recall (Z-2047-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30 Degree, REF DP8430 recall (Z-2048-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip Angled 30 Degree, REF recall (Z-2049-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Microflow 2.2 30 Degree, REF D recall (Z-2050-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree, REF MVS 1600A, recall (Z-2051-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree, REF MVS1601A, recall (Z-2052-2008)Bausch & Lomb Inc2008-09-16
Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reord recall (Z-1021-2007)Bausch & Lomb Inc2007-08-02
Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reu recall (Z-1022-2007)Bausch & Lomb Inc2007-08-02
Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high spe recall (Z-0495-2007)Bausch & Lomb Inc2007-05-24
Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, con recall (Z-0496-2007)Bausch & Lomb Inc2007-05-24
Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Cat recall (Z-0765-2007)Bausch & Lomb Inc2007-04-21
Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX49 recall (Z-0766-2007)Bausch & Lomb Inc2007-04-21
Contact lens solution. The product is distributed under the following trade names: Bausch recall (Z-0715-2007)Bausch & Lomb Inc2007-04-04
SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containi recall (Z-0544-05)Bausch & Lomb Inc2005-02-16
CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes. recall (Z-0264-04)Bausch & Lomb Inc2003-12-24
OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Respons recall (Z-0348-03)Bausch & Lomb Inc2002-12-19

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Every clearance here is in the API, with alerts when new ones post.