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Ophthalmic Hook

Model K3-5520 · KATENA PRODUCTS, INC. · DI 00841668103944

HNQ — Hook, Ophthalmic · Class I · 21 CFR 886.4350

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (2)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 2

11232021-03: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 2 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2.5/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device0310020405091001020304050610111202030508091204070810010304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0301
2021-1001
2022-0201
2022-0401
2022-0501
2022-0901
2022-1001
2023-0102
2023-0201
2023-0302
2023-0401
2023-0521.33
2023-0601
2023-1001
2023-1101
2023-1201
2024-0201
2024-0301
2024-0501
2024-0802
2024-0901
2024-1202
2025-0402.5
2025-0701
2025-0801.5
2025-1001
2026-0101
2026-0301
2026-0401
This device (reports/month)Average device in HNQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — KATENA PRODUCTS, INC.

  • NAI 2016-08-31 Katena Products, Inc. · 0 citations
  • NAI 2014-04-21 Katena Products Inc. · 0 citations
  • NAI 2012-02-22 Katena Products, Inc. · 0 citations