Facility

Bausch & Lomb Incorporated

8 recall(s) on record — most severe on record: Class II.

Key facts

8recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1119279
Establishment type	Manufacture Medical Device
Location	21 PARK PLACE BLVD. NORTH CLEARWATER, FL, US 33759
Registration status	Active · expires 2026
Parent company	Bausch & Lomb Incorporated (owner-operator 9913003)

Activity by year

Recalls (8)
Inspections (2)

Devices registered here (1)

Lenses, Soft Contact, Daily Wear
Product code LPL (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.5925

Recalls & enforcement

Class IITerminated2018-08-08
The back cap separates from the body of the vitrectomy cutter.
Class IITerminated2017-03-03
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration…
Class IITerminated2016-10-12
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). Further investigation found that repackaged Algerbrush-I…
Class IITerminated2016-09-19
Product was found to contain excess residual levels of hydrogen peroxide.
Class IITerminated2016-07-11
Possible dull knife edge
Class IITerminated2015-09-03
The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.
Class IITerminated2014-11-04
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
Class IITerminated2012-08-31
Posterior fluidics modules installed in the system may need to be recalibrated.

FDA inspections (2)

VAI2017-11-03
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-04-05
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Bausch & Lomb Incorporated (FEI 1119279) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1119279-bausch-lomb-incorporated/

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