Bausch & Lomb, Inc.
Bausch & Lomb, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2019, with 18 FDA device recalls on record.
Top product codes for Bausch & Lomb, Inc.
FDA recalls by Bausch & Lomb, Inc.
10 most recent of 18- Z-3277-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
- Z-3269-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Z-3276-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
- Z-3270-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF SE5423WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Z-3267-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
- Z-3266-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
- Z-3272-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
- Z-3265-2018 — Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
- Z-3275-2018 — Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
- Z-3271-2018 — Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bausch & Lomb, Inc.
- K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded
- K173480 — Crystalsert Lens Delivery System
- K151102 — Bausch + Lomb Injector System
- K131208 — BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
- K122575 — BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
- K113852 — BAUSCH & LOMB IOL INJECTOR
- K112909 — OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
- K111877 — EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
- K112192 — NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
- K101325 — STELLARIS PC VISION ENHANCEMENT SYSTEM
- K083757 — BPZ02 MULTIPURPOSE SOLUTION
- K082473 — BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
- K082944 — CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
- K082132 — BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
- K080755 — SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
- K073023 — STERILS SINGLE-USE I/A HANDPIECES
- K073184 — BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
- K071266 — BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
- K071043 — BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
- K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
- K063331 — BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
- K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM
- K050948 — PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
- K050157 — MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
- K041998 — PHACO CHOP NEEDLES
- K040204 — ZYOPTIX XP MICROKERATOME
- K033941 — MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
- K033653 — VENTURI PHACO PACK
- K031646 — BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
- K022760 — MILLENNIUM MICROSURGICAL SYSTEM
- K021640 — HANSATOME EXCELLUS MICROKERATOME
- K013232 — CYBERCASES BY BAUSCH & LOMB
- K012873 — DOCUMENTING LASER SLIT LAMP, DP 2010
- K011796 — RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
- K012435 — ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
- K011718 — BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
- K011199 — PROVIEW EYE PRESSURE MONITOR
- K010260 — HANSATOME MICROKERATOME
- K002823 — RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
- K001539 — RENU MULTIPLUS MULTI-PURPOSE SOLUTION
- K000247 — BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
- K994125 — BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
- K993039 — VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
- K990422 — RENU MULTIPLUS MULTI-PURPOSE SOLUTION
- K983225 — BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
- K983894 — BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
- K982775 — BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
- K980591 — RENU MULTIPLUS LUBRICATING & REWETTING DROPS
- K974780 — SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
- K974723 — RENU MULTIPLUS MULTI-PURPOSE SOLUTION
- K973921 — BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
- K972454 — OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
- K944895 — BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
- K941370 — BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
- K935561 — INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
- K926476 — SOUNDCHOICE WITH VARIABLE SLOPE
- K923735 — SOUNDCHOICE K-AMP
- K921999 — INTERJET(TM) GINGIVAL CARE INSTRUMENT
- K921122 — SOUNDCHOICE BTE
- K911726 — PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
- K910610 — INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
- K896685 — BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
- K890514 — PRE-MOISTENED CLEANSING PAD
- K874224 — BIO-COR II COLLAGEN CORNEAL SHIELD
- K874225 — BIO-COR EXT COLLAGEN CORNEAL SHIELD
- K874364 — BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
- K843511 — BAUSCH & LOMB CLEANING PAD
- K862517 — BAUSCH & LOMB CONTACT LENS VIEWER
- K862518 — BAUSCH & LOMB VERTOMETER V-5
- K862519 — BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR
- K862515 — BAUSCH & LOMB CSL-1000 SLIT LAMP
- K862516 — BAUSCH & LOMB OSL-2000 SLIT LAMP
- K862520 — BAUSCH & LOMB PSL-3000 SLIT LAMP
- K862521 — BAUSCH & LOMB GR-3 REFRACTOR
- K854968 — BAUSCH & LOMB LENS CARRYING CASE
- K852384 — SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
- K850767 — SPECTRONIC 2000 SPECTROPHOTOMETER
- K850709 — SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER
- K850708 — SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER
- K841316 — FLATPACK CARRYING CASE
- K832706 — SENSITIVE EYES
- K820511 — BAUSCH & LOMB STERILE ALL PURPOSE SOLU
- K820818 — CONCENTRATED CLEANER FOR HARD CONTACTS
- K812896 — I.V.E. REFRACTION SYSTEM
- K791499 — RAY-BAN SUN GLASSES
- K791104 — B & L OPHTHALMIC INSTRUMENT STAND
- K791105 — B & L OPHTHALMIC CHAIR
- K781658 — PROJECTOR, ACCU-CHART ACUITY
- K781138 — SPECTROPHOTOMETER
- K780902 — FISHER SPECTROPHOTOMETER
- K780903 — CLINICAL ANALYZER SYSTEM
- K770652 — FLUORESCENCE ILLUMINATOR ACCESSORY
Data sourced from openFDA. This site is unofficial and independent of the FDA.