Alcon Grieshaber 611.74Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07612717012226), received between Aug 26, 2022 and Mar 16, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT A SMALL SILICONE STOPPER/SLIDER FROM AN OPHTHALMIC IRIS RETRACTOR¿USED TO SECURE THE IRIS HOOK¿WAS FOUND TO BE MISSING DURING SURGERY. THE SURGEON WAS CONFIDENT THAT THE SILICONE COMPONENT WAS NOT INSIDE THE PATIENT¿S EYE. AN ATTEMPT WAS MADE TO LOCATE IT UNDER THE LOWER EYELID (FORNIX AREA), BUT IT WAS NOT VISUALIZED. THE SURGEON CHOSE NOT TO CONTINUE SEARCHING BENEATH THE EYELIDS TO AVOID CAUSING POTENTIAL TRAUMA. IT WAS NOT VISUALIZED AND WITHIN IT COULD NOT BE FOUND. THE PATIENT WILL BE REASSESSED AT THE POSTOPERATIVE APPOINTMENT. DETAILS REGARDING THE PROCEDURE AND THE COMPLETION OF THE SURGERY ARE UNKNOWN. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604383 ↗
• MalfunctionJun 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT DURING A CATARACT VITRECTOMY COMBINATION PROCEDURE TWO BALLS OF THE RETRACTOR WHICH ACT AS STOPPER FOR HOLDING COULD NOT BE RETRIEVED. THE PATIENT WAS INFORMED THAT THERE WAS POSSIBILITY THAT THOSE BALLS REMAINED IN THE PATIENT'S EYE. THE SURGERY WAS PERFORMED AND COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161943 ↗
• MalfunctionMar 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT AFTER A CATARACT SURGERY, IT WAS OBSERVED UNDER A MICROSCOPE THAT AN OPHTHALMIC RETRACTOR STOPPER PART WAS TORN. THE DAMAGED PART WAS A CIRCULAR SILICONE PART, EXTRAOCULAR. THE RETRACTOR WAS REMOVED AT THE END OF THE SURGERY AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495175 ↗
• MalfunctionAug 26, 2022Difficult to Advance; Difficult to Advance

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC RETRACTORS DID NOT SLIDE INTO THE EYE DURING A CATARACT SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300443 ↗