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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-09-09 | NAI | No action indicated | Bausch & Lomb Incorporated | 0 |
| 2024-09-09 | NAI | No action indicated | Bausch & Lomb Incorporated | 0 |
| 2019-10-10 | NAI | No action indicated | Bausch & Lomb, Inc. | 0 |
| 2019-10-10 | NAI | No action indicated | Bausch & Lomb, Inc. | 0 |
| 2019-10-08 | NAI | No action indicated | Bausch & Lomb Inc | 0 |
| 2019-10-08 | NAI | No action indicated | Bausch & Lomb Inc | 0 |
| 2018-08-28 | NAI | No action indicated | Bausch & Lomb Incorporated | 0 |
| 2018-08-28 | NAI | No action indicated | Bausch & Lomb Incorporated | 0 |
| 2018-07-13 | VAI | Voluntary action indicated | Bausch & Lomb, Incorporated | 2 |
| 2018-07-13 | VAI | Voluntary action indicated | Bausch & Lomb, Incorporated | 2 |
| 2018-02-23 | NAI | No action indicated | Bausch & Lomb Incorporated | 0 |
| 2018-02-23 | NAI | No action indicated | Bausch & Lomb Incorporated | 0 |
| 2017-11-03 | VAI | Voluntary action indicated | Bausch & Lomb Surgical, Inc. | 4 |
| 2017-07-28 | NAI | No action indicated | Total Titanium Inc | 0 |
| 2017-04-05 | VAI | Voluntary action indicated | Bausch & Lomb Surgical, Inc. | 4 |
| 2017-02-15 | VAI | Voluntary action indicated | Bausch & Lomb Incorporated | 1 |
| 2017-02-15 | VAI | Voluntary action indicated | Bausch & Lomb Incorporated | 1 |
| 2016-10-05 | VAI | Voluntary action indicated | Bausch & Lomb Incorporated | 5 |
| 2016-10-05 | VAI | Voluntary action indicated | Bausch & Lomb Incorporated | 5 |
| 2016-06-10 | NAI | No action indicated | Bausch & Lomb Inc | 0 |
| 2012-06-11 | WL | Warning Letter | Valeant Amsterdam Logistics Center | — |
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