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.
61 linked reportsMalfunction 59Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.4 |
| 2019-02 | 0 | 2.86 |
| 2019-03 | 0 | 2.2 |
| 2019-04 | 0 | 3.25 |
| 2019-05 | 0 | 2.55 |
| 2019-06 | 0 | 2.82 |
| 2019-07 | 0 | 2.55 |
| 2019-08 | 0 | 3.14 |
| 2019-09 | 0 | 1.82 |
| 2019-10 | 0 | 2.06 |
| 2019-11 | 0 | 2.38 |
| 2019-12 | 0 | 2.89 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 2.94 |
| 2020-03 | 0 | 3.83 |
| 2020-04 | 0 | 3 |
| 2020-05 | 0 | 2.46 |
| 2020-06 | 0 | 2.4 |
| 2020-07 | 0 | 2.33 |
| 2020-08 | 0 | 4.17 |
| 2020-09 | 0 | 4 |
| 2020-10 | 0 | 4.57 |
| 2020-11 | 0 | 3.14 |
| 2020-12 | 0 | 4.2 |
| 2021-01 | 0 | 3.5 |
| 2021-02 | 0 | 3.5 |
| 2021-03 | 0 | 9.33 |
| 2021-04 | 0 | 1.83 |
| 2021-05 | 0 | 4.5 |
| 2021-06 | 0 | 5.54 |
| 2021-07 | 0 | 2.29 |
| 2021-08 | 0 | 4.18 |
| 2021-09 | 0 | 2.45 |
| 2021-10 | 0 | 2.86 |
| 2021-11 | 0 | 3 |
| 2021-12 | 0 | 4.57 |
| 2022-01 | 0 | 1.8 |
| 2022-02 | 0 | 8.5 |
| 2022-03 | 0 | 2.43 |
| 2022-04 | 0 | 2.43 |
| 2022-05 | 0 | 6.21 |
| 2022-06 | 0 | 3.6 |
| 2022-07 | 0 | 4 |
| 2022-08 | 0 | 3.06 |
| 2022-09 | 0 | 3.71 |
| 2022-10 | 0 | 4.7 |
| 2022-11 | 0 | 14.73 |
| 2022-12 | 0 | 5.31 |
| 2023-01 | 0 | 4.54 |
| 2023-02 | 0 | 8.43 |
| 2023-03 | 0 | 4 |
| 2023-04 | 0 | 5.62 |
| 2023-05 | 0 | 6.33 |
| 2023-06 | 0 | 5.13 |
| 2023-07 | 0 | 3.6 |
| 2023-08 | 0 | 2.67 |
| 2023-09 | 0 | 4 |
| 2023-10 | 13 | 2.93 |
| 2023-11 | 2 | 3.25 |
| 2023-12 | 2 | 4.93 |
| 2024-01 | 0 | 3.75 |
| 2024-02 | 0 | 4.54 |
| 2024-03 | 4 | 3.69 |
| 2024-04 | 1 | 3.06 |
| 2024-05 | 2 | 2.13 |
| 2024-06 | 3 | 3.76 |
| 2024-07 | 0 | 3.8 |
| 2024-08 | 0 | 3.75 |
| 2024-09 | 3 | 2.71 |
| 2024-10 | 2 | 2.93 |
| 2024-11 | 0 | 5.69 |
| 2024-12 | 0 | 2.75 |
| 2025-01 | 3 | 3.9 |
| 2025-02 | 1 | 2.67 |
| 2025-03 | 1 | 3.38 |
| 2025-04 | 0 | 3 |
| 2025-05 | 3 | 5.19 |
| 2025-06 | 2 | 3.6 |
| 2025-07 | 2 | 2.23 |
| 2025-08 | 7 | 3.36 |
| 2025-09 | 1 | 2.89 |
| 2025-10 | 2 | 5.24 |
| 2025-11 | 1 | 3.94 |
| 2025-12 | 0 | 3.88 |
| 2026-01 | 2 | 12.36 |
| 2026-02 | 3 | 4.08 |
| 2026-03 | 0 | 4.73 |
| 2026-04 | 1 | 4.64 |
| 2026-05 | 0 | 6.05 |
| 2026-06 | 0 | 7.92 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-03 | 2523835-2026-00351 | Malfunction | Available | exact di |
| 2026-02-20 | 2523835-2026-00189 | Malfunction | Available | exact di |
| 2026-02-20 | 2523835-2026-00188 | Malfunction | Available | exact di |
| 2026-02-10 | 2523835-2026-00138 | Malfunction | Available | exact di |
| 2026-01-20 | 2523835-2026-00090 | Malfunction | Available | exact di |
| 2026-01-08 | 2523835-2026-00039 | Malfunction | Available | exact di |
| 2025-11-19 | 2523835-2025-01212 | Malfunction | Available | exact di |
| 2025-10-30 | 2523835-2025-01133 | Malfunction | Available | exact di |
| 2025-10-23 | 2523835-2025-01112 | Malfunction | Available | exact di |
| 2025-09-12 | 2523835-2025-00967 | Malfunction | Available | exact di |
| 2025-08-29 | 2523835-2025-00926 | Malfunction | Available | exact di |
| 2025-08-28 | 2523835-2025-00924 | Malfunction | Available | exact di |
| 2025-08-28 | 2523835-2025-00925 | Malfunction | Available | exact di |
| 2025-08-22 | 2523835-2025-00893 | Malfunction | Available | exact di |
| 2025-08-22 | 2523835-2025-00899 | Malfunction | Available | exact di |
Showing 1–15 of 61
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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