Recall Register

Bausch & Lomb Inc Irb: FDA recalls

FDA enforcement reports name Bausch & Lomb Inc Irb as the recalling firm in 4 events. The events have 48 product records. The recalls started from 2015 to 2017. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

4 events, newest first.

FDA enforcement events of Bausch & Lomb Inc Irb
InitiatedProduct (first record)TypeClassRecordsStatus
3 Mar 2017LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.DeviceClass II44Terminated
19 Sep 2016PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily…DeviceClass II1Terminated
11 Jul 2016Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.DeviceClass II2Terminated
3 Sep 2015BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Bausch & Lomb Inc Irb: events for each product type
TypeEvents
Device4
Bausch & Lomb Inc Irb: events in each class
ClassEvents
Class II4
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Bausch & Lomb Inc Irb, by the year that the recall started. The largest year is 2016, with 2 events.

Official channels

Cite this page

Recall Register. Bausch & Lomb Inc Irb: FDA recalls. https://recallregister.com/firm/bausch-lomb-inc-irb/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
NY

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Bausch & Lomb Inc Irb have?
Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Bausch & Lomb Inc Irb?
FDA event 76874, which the firm started on 3 Mar 2017. The first product in the record is: LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
How many FDA recalls of Bausch & Lomb Inc Irb have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.