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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-09-09NAINo action indicatedBausch & Lomb Incorporated0
2024-09-09NAINo action indicatedBausch & Lomb Incorporated0
2019-10-10NAINo action indicatedBausch & Lomb, Inc.0
2019-10-10NAINo action indicatedBausch & Lomb, Inc.0
2019-10-08NAINo action indicatedBausch & Lomb Inc0
2019-10-08NAINo action indicatedBausch & Lomb Inc0
2018-08-28NAINo action indicatedBausch & Lomb Incorporated0
2018-08-28NAINo action indicatedBausch & Lomb Incorporated0
2018-07-13VAIVoluntary action indicatedBausch & Lomb, Incorporated2
2018-07-13VAIVoluntary action indicatedBausch & Lomb, Incorporated2
2018-02-23NAINo action indicatedBausch & Lomb Incorporated0
2018-02-23NAINo action indicatedBausch & Lomb Incorporated0
2017-11-03VAIVoluntary action indicatedBausch & Lomb Surgical, Inc.4
2017-07-28NAINo action indicatedTotal Titanium Inc0
2017-04-05VAIVoluntary action indicatedBausch & Lomb Surgical, Inc.4
2017-02-15VAIVoluntary action indicatedBausch & Lomb Incorporated1
2017-02-15VAIVoluntary action indicatedBausch & Lomb Incorporated1
2016-10-05VAIVoluntary action indicatedBausch & Lomb Incorporated5
2016-10-05VAIVoluntary action indicatedBausch & Lomb Incorporated5
2016-06-10NAINo action indicatedBausch & Lomb Inc0
2012-06-11WLWarning LetterValeant Amsterdam Logistics Center—
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