Ophthalmic Forceps · recalls, adverse events, clearances

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.

2 linked reportsMalfunction 2

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-03	0	1.5
2019-05	0	1
2019-07	0	1.5
2019-09	0	1
2019-11	0	3
2020-01	0	1
2021-03	0	2
2021-04	0	2
2021-05	0	1
2021-06	0	1
2021-07	0	2
2021-08	0	2
2021-09	0	1.33
2021-10	0	1.67
2021-11	0	1.33
2021-12	0	2
2022-01	0	1
2022-02	0	1
2022-03	0	1
2022-04	0	1
2022-05	0	1.5
2022-06	0	1.67
2022-07	0	1
2022-08	0	2.17
2022-09	0	1.33
2022-10	0	2.33
2022-11	0	3.5
2022-12	0	1
2023-01	0	1.75
2023-02	0	1.33
2023-03	0	1
2023-04	0	2
2023-05	0	1
2023-06	0	2.64
2023-07	0	1
2023-08	0	1.4
2023-09	0	2
2023-10	0	1.33
2023-11	0	1
2023-12	0	1.25
2024-01	0	1.5
2024-02	0	1
2024-03	0	1
2024-04	0	1.38
2024-05	0	1
2024-06	0	1.75
2024-07	0	1.67
2024-08	0	1.5
2024-09	0	1
2024-10	0	1
2024-11	0	2
2024-12	0	1.4
2025-01	0	1.25
2025-02	0	1.4
2025-03	0	1.75
2025-04	0	1.8
2025-05	0	1.83
2025-06	0	1
2025-07	0	1.33
2025-08	0	1
2025-09	0	1
2025-10	0	1
2025-11	0	1.29
2025-12	0	2
2026-01	0	2.4
2026-02	0	1.5
2026-03	0	1
2026-04	2	1.43
2026-05	0	1
2026-06	0	1.25

This device (reports/month)Average device in HNR (reports/device/month)

Failure-mode summaryAI-generated

2 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-04-09	3010692967-2026-00011	Malfunction	Available	exact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2016-08-31	NAI	No action indicated	Katena Products, Inc.
2014-04-21	NAI	No action indicated	Katena Products Inc.
2012-02-22	NAI	No action indicated	Katena Products, Inc.

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