Bausch And Lomb recalls
Bausch And Lomb appears in 28 official U.S. recall notices indexed by RecallRadar, most recently on 2019-06-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 28 |
|---|---|
| Published | 2012-06-20 to 2019-06-19 |
| By agency | FDA Device (19), FDA Drug (9) |
| By classification | Class II (23), Class III (4), Class I (1) |
| By status | terminated (28) |
| Distribution named in notices | AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NY, OH, OK, OR, PA, PR, TN, TX, US, UT, WI, WV |
Recalls
- Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North…
FDA Drug · Class III · 2019-06-19 · Bausch And Lomb
Reason: Failed Stability Specifications: Out of specification for viscosity. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb
Reason: The back cap separates from the body of the vitrectomy cutter. - NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distribut…
FDA Drug · Class II · 2017-06-21 · Bausch And Lomb
Reason: CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot. - Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the p…
FDA Device · Class II · 2017-01-18 · Bausch And Lomb
Reason: According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond)… - Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-…
FDA Drug · Class III · 2016-02-03 · Bausch And Lomb
Reason: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. - Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only
FDA Drug · Class III · 2016-02-03 · Bausch And Lomb
Reason: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. - Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only
FDA Drug · Class III · 2016-02-03 · Bausch And Lomb
Reason: Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. - Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only
FDA Drug · Class II · 2015-08-26 · Bausch And Lomb
Reason: Lack of Assurance of Sterility: Failed preservative effectiveness testing. - Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhance…
FDA Device · Class II · 2014-12-31 · Bausch And Lomb
Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. - Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhanc…
FDA Device · Class II · 2014-12-31 · Bausch And Lomb
Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. - Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Device · Class II · 2014-12-31 · Bausch And Lomb
Reason: A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. - Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterpr…
FDA Drug · Class II · 2014-07-02 · Bausch And Lomb
Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. - Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01…
FDA Drug · Class II · 2014-07-02 · Bausch And Lomb
Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye. - Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and…
FDA Device · Class I · 2013-01-23 · Bausch And Lomb
Reason: Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and Amvisc Plus sterile glass syringes. The cannulas may leak visc… - Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and re…
FDA Device · Class II · 2012-12-26 · Bausch And Lomb
Reason: Posterior fluidics modules installed in the system may need to be recalibrated. - Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL…
FDA Drug · Class II · 2012-06-20 · Bausch And Lomb
Reason: Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at th…