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Ideal Eyes, Speed-Lock

Model 0502104030 · STRYKER CORPORATION · DI 07613327062113

HRX — Arthroscope · Class II · 21 CFR 888.1100

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 (77)

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: 75 · Injury: 2

3710132019-01: 0 reports for this device; peer average 13.41/device2019-02: 0 reports for this device; peer average 3.29/device2019-03: 0 reports for this device; peer average 3.78/device2019-04: 0 reports for this device; peer average 4.27/device2019-05: 0 reports for this device; peer average 4.18/device2019-06: 1 reports for this device; peer average 3.67/device2019-07: 0 reports for this device; peer average 3.38/device2019-08: 1 reports for this device; peer average 3.9/device2019-09: 0 reports for this device; peer average 4.55/device2019-10: 0 reports for this device; peer average 5.02/device2019-11: 0 reports for this device; peer average 4.63/device2019-12: 0 reports for this device; peer average 5.21/device2020-01: 0 reports for this device; peer average 5.18/device2020-02: 1 reports for this device; peer average 5.84/device2020-03: 2 reports for this device; peer average 5.61/device2020-04: 0 reports for this device; peer average 5/device2020-05: 3 reports for this device; peer average 3.51/device2020-06: 0 reports for this device; peer average 5.69/device2020-07: 1 reports for this device; peer average 6.15/device2020-08: 0 reports for this device; peer average 5.71/device2020-09: 1 reports for this device; peer average 7.49/device2020-10: 0 reports for this device; peer average 8.72/device2020-11: 1 reports for this device; peer average 5.95/device2020-12: 1 reports for this device; peer average 8.86/device2021-01: 0 reports for this device; peer average 6.31/device2021-02: 0 reports for this device; peer average 5.77/device2021-03: 1 reports for this device; peer average 7.8/device2021-04: 0 reports for this device; peer average 6.1/device2021-05: 0 reports for this device; peer average 5.63/device2021-06: 1 reports for this device; peer average 5.7/device2021-07: 1 reports for this device; peer average 4.96/device2021-08: 0 reports for this device; peer average 5.25/device2021-09: 1 reports for this device; peer average 3.47/device2021-10: 0 reports for this device; peer average 5.1/device2021-11: 0 reports for this device; peer average 3.78/device2021-12: 0 reports for this device; peer average 5.41/device2022-01: 0 reports for this device; peer average 4.97/device2022-02: 1 reports for this device; peer average 3.74/device2022-03: 1 reports for this device; peer average 4.39/device2022-04: 4 reports for this device; peer average 4.17/device2022-05: 3 reports for this device; peer average 4.13/device2022-06: 5 reports for this device; peer average 4.35/device2022-07: 0 reports for this device; peer average 4.38/device2022-08: 0 reports for this device; peer average 4.33/device2022-09: 0 reports for this device; peer average 4.16/device2022-10: 1 reports for this device; peer average 4.1/device2022-11: 1 reports for this device; peer average 4.7/device2022-12: 6 reports for this device; peer average 4.67/device2023-01: 2 reports for this device; peer average 5.09/device2023-02: 1 reports for this device; peer average 4.36/device2023-03: 1 reports for this device; peer average 5.24/device2023-04: 1 reports for this device; peer average 4.82/device2023-05: 0 reports for this device; peer average 4.84/device2023-06: 0 reports for this device; peer average 4.5/device2023-07: 1 reports for this device; peer average 4.29/device2023-08: 0 reports for this device; peer average 5.05/device2023-09: 1 reports for this device; peer average 4.83/device2023-10: 0 reports for this device; peer average 4.41/device2023-11: 1 reports for this device; peer average 7.93/device2023-12: 3 reports for this device; peer average 8.8/device2024-01: 2 reports for this device; peer average 6.2/device2024-02: 1 reports for this device; peer average 6.57/device2024-03: 1 reports for this device; peer average 5.26/device2024-04: 0 reports for this device; peer average 5.97/device2024-05: 0 reports for this device; peer average 8.82/device2024-06: 0 reports for this device; peer average 8.82/device2024-07: 1 reports for this device; peer average 4.91/device2024-08: 0 reports for this device; peer average 4.86/device2024-09: 0 reports for this device; peer average 4.76/device2024-10: 0 reports for this device; peer average 6.15/device2024-11: 0 reports for this device; peer average 5.22/device2024-12: 5 reports for this device; peer average 7.58/device2025-01: 0 reports for this device; peer average 8.91/device2025-02: 0 reports for this device; peer average 6.11/device2025-03: 0 reports for this device; peer average 5.08/device2025-04: 0 reports for this device; peer average 5.43/device2025-05: 3 reports for this device; peer average 5.98/device2025-06: 1 reports for this device; peer average 5.09/device2025-07: 0 reports for this device; peer average 5.28/device2025-08: 0 reports for this device; peer average 4.37/device2025-09: 0 reports for this device; peer average 4.58/device2025-10: 3 reports for this device; peer average 5.09/device2025-11: 1 reports for this device; peer average 5.68/device2025-12: 1 reports for this device; peer average 5.94/device2026-01: 0 reports for this device; peer average 5.53/device2026-02: 4 reports for this device; peer average 5.56/device2026-03: 1 reports for this device; peer average 5.59/device2026-04: 0 reports for this device; peer average 7/device2026-05: 4 reports for this device; peer average 4.7/device2026-06: 0 reports for this device; peer average 4.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01013.41
2019-0203.29
2019-0303.78
2019-0404.27
2019-0504.18
2019-0613.67
2019-0703.38
2019-0813.9
2019-0904.55
2019-1005.02
2019-1104.63
2019-1205.21
2020-0105.18
2020-0215.84
2020-0325.61
2020-0405
2020-0533.51
2020-0605.69
2020-0716.15
2020-0805.71
2020-0917.49
2020-1008.72
2020-1115.95
2020-1218.86
2021-0106.31
2021-0205.77
2021-0317.8
2021-0406.1
2021-0505.63
2021-0615.7
2021-0714.96
2021-0805.25
2021-0913.47
2021-1005.1
2021-1103.78
2021-1205.41
2022-0104.97
2022-0213.74
2022-0314.39
2022-0444.17
2022-0534.13
2022-0654.35
2022-0704.38
2022-0804.33
2022-0904.16
2022-1014.1
2022-1114.7
2022-1264.67
2023-0125.09
2023-0214.36
2023-0315.24
2023-0414.82
2023-0504.84
2023-0604.5
2023-0714.29
2023-0805.05
2023-0914.83
2023-1004.41
2023-1117.93
2023-1238.8
2024-0126.2
2024-0216.57
2024-0315.26
2024-0405.97
2024-0508.82
2024-0608.82
2024-0714.91
2024-0804.86
2024-0904.76
2024-1006.15
2024-1105.22
2024-1257.58
2025-0108.91
2025-0206.11
2025-0305.08
2025-0405.43
2025-0535.98
2025-0615.09
2025-0705.28
2025-0804.37
2025-0904.58
2025-1035.09
2025-1115.68
2025-1215.94
2026-0105.53
2026-0245.56
2026-0315.59
2026-0407
2026-0544.7
2026-0604.85
This device (reports/month)Average device in HRX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
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  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations