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A.C.S® (Alcon Closure System)

Model 8065698001 · Alcon Laboratories, Inc. · DI 00380656980018

GAR — Suture, Nonabsorbable, Synthetic, Polyamide · Class II · 21 CFR 878.5020

UDILibrary device dossier · generated 2026-09-15 · 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 (73)

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: 63 · Injury: 10

4711152019-01: 0 reports for this device; peer average 1.4/device2019-02: 0 reports for this device; peer average 2.86/device2019-03: 0 reports for this device; peer average 2.2/device2019-04: 0 reports for this device; peer average 3.25/device2019-05: 0 reports for this device; peer average 2.55/device2019-06: 0 reports for this device; peer average 2.82/device2019-07: 0 reports for this device; peer average 2.55/device2019-08: 0 reports for this device; peer average 3.14/device2019-09: 0 reports for this device; peer average 1.82/device2019-10: 0 reports for this device; peer average 2.06/device2019-11: 0 reports for this device; peer average 2.38/device2019-12: 0 reports for this device; peer average 2.89/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2.94/device2020-03: 0 reports for this device; peer average 3.83/device2020-04: 0 reports for this device; peer average 3/device2020-05: 0 reports for this device; peer average 2.46/device2020-06: 0 reports for this device; peer average 2.4/device2020-07: 0 reports for this device; peer average 2.33/device2020-08: 0 reports for this device; peer average 4.17/device2020-09: 0 reports for this device; peer average 4/device2020-10: 0 reports for this device; peer average 4.57/device2020-11: 0 reports for this device; peer average 3.14/device2020-12: 0 reports for this device; peer average 4.2/device2021-01: 0 reports for this device; peer average 3.5/device2021-02: 0 reports for this device; peer average 3.5/device2021-03: 0 reports for this device; peer average 9.33/device2021-04: 0 reports for this device; peer average 1.83/device2021-05: 0 reports for this device; peer average 4.5/device2021-06: 0 reports for this device; peer average 5.54/device2021-07: 0 reports for this device; peer average 2.29/device2021-08: 0 reports for this device; peer average 4.18/device2021-09: 0 reports for this device; peer average 2.45/device2021-10: 0 reports for this device; peer average 2.86/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 4.57/device2022-01: 0 reports for this device; peer average 1.8/device2022-02: 0 reports for this device; peer average 8.5/device2022-03: 0 reports for this device; peer average 2.43/device2022-04: 1 reports for this device; peer average 2.43/device2022-05: 0 reports for this device; peer average 6.21/device2022-06: 0 reports for this device; peer average 3.6/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 3.06/device2022-09: 0 reports for this device; peer average 3.71/device2022-10: 0 reports for this device; peer average 4.7/device2022-11: 0 reports for this device; peer average 14.73/device2022-12: 0 reports for this device; peer average 5.31/device2023-01: 3 reports for this device; peer average 4.54/device2023-02: 0 reports for this device; peer average 8.43/device2023-03: 0 reports for this device; peer average 4/device2023-04: 0 reports for this device; peer average 5.62/device2023-05: 0 reports for this device; peer average 6.33/device2023-06: 0 reports for this device; peer average 5.13/device2023-07: 0 reports for this device; peer average 3.6/device2023-08: 0 reports for this device; peer average 2.67/device2023-09: 0 reports for this device; peer average 4/device2023-10: 3 reports for this device; peer average 2.93/device2023-11: 1 reports for this device; peer average 3.25/device2023-12: 3 reports for this device; peer average 4.93/device2024-01: 0 reports for this device; peer average 3.75/device2024-02: 4 reports for this device; peer average 4.54/device2024-03: 4 reports for this device; peer average 3.69/device2024-04: 1 reports for this device; peer average 3.06/device2024-05: 0 reports for this device; peer average 2.13/device2024-06: 1 reports for this device; peer average 3.76/device2024-07: 0 reports for this device; peer average 3.8/device2024-08: 2 reports for this device; peer average 3.75/device2024-09: 1 reports for this device; peer average 2.71/device2024-10: 3 reports for this device; peer average 2.93/device2024-11: 1 reports for this device; peer average 5.69/device2024-12: 1 reports for this device; peer average 2.75/device2025-01: 5 reports for this device; peer average 3.9/device2025-02: 1 reports for this device; peer average 2.67/device2025-03: 0 reports for this device; peer average 3.38/device2025-04: 5 reports for this device; peer average 3/device2025-05: 1 reports for this device; peer average 5.19/device2025-06: 0 reports for this device; peer average 3.6/device2025-07: 3 reports for this device; peer average 2.23/device2025-08: 1 reports for this device; peer average 3.36/device2025-09: 3 reports for this device; peer average 2.89/device2025-10: 3 reports for this device; peer average 5.24/device2025-11: 2 reports for this device; peer average 3.94/device2025-12: 6 reports for this device; peer average 3.88/device2026-01: 4 reports for this device; peer average 12.36/device2026-02: 0 reports for this device; peer average 4.08/device2026-03: 5 reports for this device; peer average 4.73/device2026-04: 3 reports for this device; peer average 4.64/device2026-05: 0 reports for this device; peer average 6.05/device2026-06: 2 reports for this device; peer average 7.92/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.4
2019-0202.86
2019-0302.2
2019-0403.25
2019-0502.55
2019-0602.82
2019-0702.55
2019-0803.14
2019-0901.82
2019-1002.06
2019-1102.38
2019-1202.89
2020-0103
2020-0202.94
2020-0303.83
2020-0403
2020-0502.46
2020-0602.4
2020-0702.33
2020-0804.17
2020-0904
2020-1004.57
2020-1103.14
2020-1204.2
2021-0103.5
2021-0203.5
2021-0309.33
2021-0401.83
2021-0504.5
2021-0605.54
2021-0702.29
2021-0804.18
2021-0902.45
2021-1002.86
2021-1103
2021-1204.57
2022-0101.8
2022-0208.5
2022-0302.43
2022-0412.43
2022-0506.21
2022-0603.6
2022-0704
2022-0803.06
2022-0903.71
2022-1004.7
2022-11014.73
2022-1205.31
2023-0134.54
2023-0208.43
2023-0304
2023-0405.62
2023-0506.33
2023-0605.13
2023-0703.6
2023-0802.67
2023-0904
2023-1032.93
2023-1113.25
2023-1234.93
2024-0103.75
2024-0244.54
2024-0343.69
2024-0413.06
2024-0502.13
2024-0613.76
2024-0703.8
2024-0823.75
2024-0912.71
2024-1032.93
2024-1115.69
2024-1212.75
2025-0153.9
2025-0212.67
2025-0303.38
2025-0453
2025-0515.19
2025-0603.6
2025-0732.23
2025-0813.36
2025-0932.89
2025-1035.24
2025-1123.94
2025-1263.88
2026-01412.36
2026-0204.08
2026-0354.73
2026-0434.64
2026-0506.05
2026-0627.92
This device (reports/month)Average device in GAR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Alcon Laboratories, Inc.

  • NAI 2025-05-01 Alcon Research, LLC · 0 citations
  • VAI 2024-06-12 Alcon Research, LTD. · 0 citations
  • NAI 2023-02-03 Ciba Vision GmbH · 0 citations
  • NAI 2022-09-15 Alcon Research, LLC · 0 citations
  • NAI 2022-09-15 Alcon Research, LLC · 0 citations
  • VAI 2022-08-26 Pt Ciba Vision Batam · 0 citations
  • NAI 2021-08-24 Alcon Research LLC · 0 citations
  • NAI 2019-12-05 Alcon Research, LLC · 1 citations
  • NAI 2019-11-21 Alcon Laboratories Ireland, Ltd · 0 citations
  • NAI 2019-10-24 Alcon Research LLC · 0 citations
  • NAI 2018-03-19 Alcon Research Ltd · 0 citations
  • NAI 2017-01-17 Alcon Research LLC · 0 citations
  • NAI 2017-01-17 Alcon Research LLC · 0 citations
  • VAI 2016-11-17 CIBA VISION Johor Sdn. Bhd. · 2 citations
  • VAI 2016-07-07 Alcon Laboratories Ireland, Ltd · 2 citations
  • VAI 2016-05-04 Alcon Research, LLC · 0 citations
  • NAI 2016-01-28 Alcon Research LLC · 0 citations
  • NAI 2016-01-21 Alcon Research, LLC · 0 citations
  • VAI 2015-09-11 Wavelight GmbH · 1 citations
  • NAI 2015-09-02 Alcon Research, LLC · 0 citations