Alcon Grieshaber 27+ Finesse 338.27Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07612717071452), received between Oct 11, 2021 and Mar 10, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Break; Activation Problem

  THE PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC LOOP HAD ACTUATION PROBLEM. THE SURGERY WAS COMPLETED ON THE SAME DAY. DETAILS OF PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE ACTUAL ISSUE WAS THAT THE LOOP FAILED TO RETRACT PROPERLY INTO THE NEEDLE ALONG WITH THE LOOP BROKEN OUTSIDE THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 24558364 ↗
• MalfunctionJan 16, 2026Break

  A PHYSICIAN REPORTED THAT DURING SURGERY AN OPHTHALMIC LOOP WAS FOUND CUT. THE SURGERY WAS COMPLETED ON THE SAME DAY. DETAILS OF THE SURGERY AND PATIENT IMPACT WERE NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24091096 ↗
• MalfunctionOct 15, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING COMBINATION SURGERY WHEN REMOVING AN OPHTHALMIC LOOP FROM INSIDE THE EYE, THE TIP OF LOOP WAS TORN OFF AND FELL BACK INTO THE EYE, BUT IT REMAINED INSIDE THE TROCAR, SO IT WAS REMOVED AGAIN DURING THE SAME SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300870 ↗
• MalfunctionApr 21, 2025Material Deformation; Material Deformation

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY WHEN THE PRODUCT WAS OPENED THE OPHTHALMIC TIP WAS FOUND TO BE BEN AND OPENING AND CLOSING FAILURE OF THE TIP OCCURRED DURING INSERTION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871306 ↗
• MalfunctionMar 27, 2024Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC LOOP TIP WAS BENT DURING COMBINATION OF CATARACT AND VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT PROVIDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985008 ↗
• MalfunctionFeb 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC OPERATING FLEXIBLE LOOP WAS FOUND TO BE FAILED. THE SURGERY WAS COMPLETED BY AN ALTERNATE PRODUCT. THERE WAS NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747459 ↗
• MalfunctionMay 4, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING THE SURGERY TOOK OUT THE LOOP AND TRIED TO INSERT IT INTO THE TROCAR BUT TIP WAS UNABLE TO BE INSERTED BACK TO THE TUBE. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16866760 ↗
• MalfunctionFeb 28, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A PHYSICIAN REPORTED THAT DURING A COMBINATION OF CATARACT AND VITRECTOMY SURGERY AN OPHTHALMIC SCRAPER TIP LOOP DID NOT COME OUT. PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451844 ↗
• MalfunctionMay 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC SCRAPER INTERNAL LIMITING MEMBRANE (ILM) WAS WEAK DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH AN OTHER PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14392788 ↗
• MalfunctionFeb 21, 2022Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A SURGERY TIP OF AN OPHTHALMIC MICRO SCRAPER WAS STUCK. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568673 ↗
• MalfunctionOct 11, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC SCRAPER CONTROL BUTTON WOULD NOT OPERATE WHICH PREVENTED THE NITINOL LOOP FROM EXTENDING DURING RETINAL SURGERY THUS, PREVENTING THE DEVICE FROM SCRAPING PROPERLY. AN ALTERNATE SCRAPER WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606043 ↗