Skip to content

Alcon Grieshaber 611.75Recalls & reported problems

Alcon Laboratories, Inc. · Flexible Iris Retractors, 6 units at 5 Hooks · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07612717012233), received between Jun 24, 2022 and Jun 24, 2022 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Capsular Bag Tear1
  • Intraocular Pressure Increased1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A LITERATURE ARTICLE STATED THAT WHILE USING THE IRIS HOOK THEY NOTED POSTERIOR CAPSULE RUPTURE OR ZONULAR FIBER RUPTURE WITH OR WITHOUT VITREOUS LOSS AND POST OPERATIVELY INTRAOCULAR PRESSURE WAS HIGH IN PATIENTS.

    Patient problems: Capsular Bag Tear; Intraocular Pressure Increased

    MAUDE report 14797164 ↗

Other Clip, iris retractor devices

All Clip, iris retractor devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.