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.
3 linked reportsMalfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-08 | 1 | 1 |
| 2022-09 | 0 | 1 |
| 2022-11 | 1 | 1 |
| 2022-12 | 1 | 1 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 6 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-12-20 | 2523835-2022-00463 | Malfunction | Available | exact di |
| 2022-11-24 | 2523835-2022-00431 | Malfunction | Available | exact di |
| 2022-08-03 | 2523835-2022-00281 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-05-01 | NAI | No action indicated | Alcon Research, LLC | 0 |
| 2024-06-12 | VAI | Voluntary action indicated | Alcon Research, LTD. | 0 |
| 2023-02-03 | NAI | No action indicated | Ciba Vision GmbH | 0 |
| 2022-09-15 | NAI | No action indicated | Alcon Research, LLC | 0 |
| 2022-09-15 | NAI | No action indicated | Alcon Research, LLC | 0 |
| 2022-08-26 | VAI | Voluntary action indicated | Pt Ciba Vision Batam | 0 |
| 2021-08-24 | NAI | No action indicated | Alcon Research LLC | 0 |
| 2019-12-05 | NAI | No action indicated | Alcon Research, LLC | 1 |
| 2019-11-21 | NAI | No action indicated | Alcon Laboratories Ireland, Ltd | 0 |
| 2019-10-24 | NAI | No action indicated | Alcon Research LLC | 0 |
| 2018-03-19 | NAI | No action indicated | Alcon Research Ltd | 0 |
| 2017-01-17 | NAI | No action indicated | Alcon Research LLC | 0 |
| 2017-01-17 | NAI | No action indicated | Alcon Research LLC | 0 |
| 2016-11-17 | VAI | Voluntary action indicated | CIBA VISION Johor Sdn. Bhd. | 2 |
| 2016-07-07 | VAI | Voluntary action indicated | Alcon Laboratories Ireland, Ltd | 2 |
| 2016-05-04 | VAI | Voluntary action indicated | Alcon Research, LLC | 0 |
| 2016-01-28 | NAI | No action indicated | Alcon Research LLC | 0 |
| 2016-01-21 | NAI | No action indicated | Alcon Research, LLC | 0 |
| 2015-09-11 | VAI | Voluntary action indicated | Wavelight GmbH | 1 |
| 2015-09-02 | NAI | No action indicated | Alcon Research, LLC | 0 |
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