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Alcon

Model 8065425120 · Alcon Laboratories, Inc. · DI 00380654251202

HNY — Cystotome · Class I · 21 CFR 886.4350

UDILibrary device dossier · generated 2026-09-11 · 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 (3)

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: 3

23562022-08: 1 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-11: 1 reports for this device; peer average 1/device2022-12: 1 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/device2024-08: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 6/device08091112101108070405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0811
2022-0901
2022-1111
2022-1211
2023-1001
2023-1101
2024-0801
2025-0701
2026-0401
2026-0506
This device (reports/month)Average device in HNY (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