223 results
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38ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·December 31, 2014
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
FDA Enforcement
Class II
·Terminated·Bausch & Lomb, Inc.·January 18, 2017
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Surgical, Inc.·July 29, 2015
Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQL·December 8, 2008
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Surgical, Inc.·February 26, 2014
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc- Greenville Solutions Plant·May 14, 2014
Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQC·July 27, 2011
Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQC·July 27, 2011
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQC·July 27, 2011
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LPN·June 30, 2009
Bausch & Lomb Stellaris 1.8mm Premium Vacuum Phaco Pack with MICS Needle, Ref: BL5114, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQC·July 27, 2011
Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer fitting to deliver the Amvis or Amvis Plus during use as a surgical aid in opthalmic anterior or posterior segment procedures.
FDA Enforcement
Class I
·Terminated·Bausch and Lomb, Incorporated·January 23, 2013
Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQL·November 19, 2009
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc·December 31, 2014
Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LYL·December 22, 2010
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQD·April 20, 2010
Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609. Product is used for For the cleaning, rinsing, disinfecting, and storage of soft contact lenses.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code LPN·August 17, 2009
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQF·November 4, 2014
Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·February 9, 2007
Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack, Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX. The firm names on the label are Bausch & Lomb Incorporated, Rochester, NY, and Bausch & Lomb Incorporated, Kingston-upon-Thames, UK.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·February 9, 2007