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"SILICONE TUBING 48 IN 0.078"" X 0.024"" LG"

Model AE-7332L · KATENA PRODUCTS, INC. · DI 00841668139455

HMX — Cannula, Ophthalmic · Class I · 21 CFR 886.4350

UDILibrary device dossier · generated 2026-09-07 · 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 (0)

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.

44881311752019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 2.67/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1.25/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.88/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 3.94/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 4.76/device2022-11: 0 reports for this device; peer average 18.35/device2022-12: 0 reports for this device; peer average 7.97/device2023-01: 0 reports for this device; peer average 16.17/device2023-02: 0 reports for this device; peer average 21.67/device2023-03: 0 reports for this device; peer average 19.63/device2023-04: 0 reports for this device; peer average 20.62/device2023-05: 0 reports for this device; peer average 19.31/device2023-06: 0 reports for this device; peer average 19.22/device2023-07: 0 reports for this device; peer average 28.53/device2023-08: 0 reports for this device; peer average 32.97/device2023-09: 0 reports for this device; peer average 16.09/device2023-10: 0 reports for this device; peer average 17.95/device2023-11: 0 reports for this device; peer average 7.7/device2023-12: 0 reports for this device; peer average 24.76/device2024-01: 0 reports for this device; peer average 13.79/device2024-02: 0 reports for this device; peer average 31.11/device2024-03: 0 reports for this device; peer average 72.77/device2024-04: 0 reports for this device; peer average 149.74/device2024-05: 0 reports for this device; peer average 170.89/device2024-06: 0 reports for this device; peer average 175.03/device2024-07: 0 reports for this device; peer average 149.34/device2024-08: 0 reports for this device; peer average 56.81/device2024-09: 0 reports for this device; peer average 48.08/device2024-10: 0 reports for this device; peer average 23.39/device2024-11: 0 reports for this device; peer average 18.62/device2024-12: 0 reports for this device; peer average 7.91/device2025-01: 0 reports for this device; peer average 1.11/device2025-02: 0 reports for this device; peer average 1.18/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1.87/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1.08/device2025-08: 0 reports for this device; peer average 1.97/device2025-09: 0 reports for this device; peer average 1.09/device2025-10: 0 reports for this device; peer average 1.09/device2025-11: 0 reports for this device; peer average 2.25/device2025-12: 0 reports for this device; peer average 1.03/device2026-01: 0 reports for this device; peer average 1.03/device2026-02: 0 reports for this device; peer average 1.43/device2026-03: 0 reports for this device; peer average 1.18/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 1.28/device2026-06: 0 reports for this device; peer average 1.88/device0405060711010405080911010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0402
2019-0501
2020-0601
2020-0701
2020-1101
2021-0101
2021-0401.5
2021-0501.5
2021-0802.67
2021-0901
2021-1101
2022-0102
2022-0203
2022-0301.25
2022-0401
2022-0502.88
2022-0601
2022-0703
2022-0803.94
2022-0901
2022-1004.76
2022-11018.35
2022-1207.97
2023-01016.17
2023-02021.67
2023-03019.63
2023-04020.62
2023-05019.31
2023-06019.22
2023-07028.53
2023-08032.97
2023-09016.09
2023-10017.95
2023-1107.7
2023-12024.76
2024-01013.79
2024-02031.11
2024-03072.77
2024-040149.74
2024-050170.89
2024-060175.03
2024-070149.34
2024-08056.81
2024-09048.08
2024-10023.39
2024-11018.62
2024-1207.91
2025-0101.11
2025-0201.18
2025-0302
2025-0401.87
2025-0501.75
2025-0601.5
2025-0701.08
2025-0801.97
2025-0901.09
2025-1001.09
2025-1102.25
2025-1201.03
2026-0101.03
2026-0201.43
2026-0301.18
2026-0402
2026-0501.28
2026-0601.88
This device (reports/month)Average device in HMX (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