Alcon Grieshaber 25+ Finesse 338.25PRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07612717071445), received between Mar 2, 2021 and May 29, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT PORTION OF THE LOOP WAS BROKEN AND LEFT INSIDE THE EYE BUT WAS LATER REMOVED. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25332929 ↗
• MalfunctionMar 6, 2026Break

  THE CUSTOMER REPORTED THAT A DURING VITREORETINAL SURGERY AN OPHTHALMIC SCRAPER LOOP WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING NEW DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530593 ↗
• MalfunctionOct 23, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING SURGERY, THE LOOP OF THE OPHTHALMIC SCRAPER DETACHED AND FELL ONTO THE FUNDUS. THE SURGERY WAS COMPLETED THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365381 ↗
• MalfunctionAug 20, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, TIP OF THE OPHTHALMIC LOOP WAS BROKEN AND FELL INTO THE EYE. THE BROKEN TIP WAS RETRIEVED FROM THE EYE DURING THE SAME PROCEDURE. THE PRODUCT WAS REPLACED WITH ANOTHER ONE, AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857380 ↗
• MalfunctionAug 13, 2025Break; Break

  A NURSE REPORTED THAT LOOP OF AN OPHTHALMIC FLEX LOOP WAS FOUND BROKEN AND CANNOT BE USED NORMALLY. SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793606 ↗
• MalfunctionJul 23, 2025Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SHEATH BECAME DETACHED FROM THE DEVICE (CIRCLED IN YELLOW IN THE PICTURE) DURING A VITRECTOMY PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, PRODUCT WAS BROKEN DURING VITRECTOMY SURGERY IN RIGHT EYE AND THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574038 ↗
• MalfunctionSep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A GOVERNMENT AGENCY REPORTED THAT DURING A CATARACT VITRECTOMY COMBINATION SURGERY AN OPHTHALMIC LOOP A WIRE GOT DISLODGED. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE PRODUCT WITH NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234744 ↗
• MalfunctionMay 8, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A CUSTOMER REPORTED THAT THE OPHTHALMIC TIP OF LOOP DID NOT COME OUT DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267323 ↗
• MalfunctionDec 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT OPHTHALMIC OPERATING SCRAPER CAME OUT DURING INSERTION. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE IS UNKNOWN. THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310993 ↗
• MalfunctionNov 27, 2023Device Fell; Device Fell

  A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC TIP OF THE FINESSE LOOP FELL OFF WHEN THE MEMBRANE ATTACHED TO THE TIP WAS SCRAPED OFF WITH A LIGHT GUIDE WHILE USING THE FINESSE LOOP. IT FELL INTO THE FUNDUS OF THE EYE, BUT IT WAS REMOVED WITH FORCEPS. THERE WAS NOTHING LEFT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209824 ↗
• MalfunctionJun 22, 2023Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SCRAPER LOOP WAS FRACTURE DURING A VITRECTOMY 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 17180496 ↗
• MalfunctionMay 15, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928766 ↗
• MalfunctionApr 13, 2023Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING MACULAR HOLE SURGERY AN OPHTHALMIC OPERATING SCRAPER TIP WAS NOT OPENING. PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730811 ↗
• MalfunctionMar 29, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC SCRAPER LOOP WAS FELL FROM THE HANDLE. PROCEDURE DETAILS WERE NOT PROVIDED AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639235 ↗
• InjuryMar 21, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY WITH MEMBRANE PEEL, AIR FLUID EXCHANGE (AFX) AND GAS FLUID EXCHANGE (GFX) LOOP FELL FROM THE HANDLE INTO THE EYE. IT WAS REMOVED BY PERFORMING ENLARGE A SCLEROTOMY TO RETRIEVE THE LOOP AND IT WAS SUTURED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16580369 ↗
• MalfunctionFeb 9, 2023Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SCRAPPER LOOP WAS NOT OPENING PROPERLY DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH OPHTHALMIC FORCEPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16331299 ↗
• MalfunctionJan 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT AN WHILE OPERATING A PATIENT'S EYE AN OPHTHALMIC SCRAPPER WASN'T ANGLED CORRECTLY AND THE TIP WAS HARD ANGLED DURING SURGERY. THE SURGERY WAS COMPLETED WITHOUT ANY PATIENT HARM OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136496 ↗
• MalfunctionJan 9, 2023Defective Component; Defective Component

  A CUSTOMER REPORTED THAT A COUPLE OF DUD FLEX LOOPS AND BRUSHES WERE WORN DOWN DURING SURGERY. THE SURGERY WAS COMPLETED WITHOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120281 ↗
• MalfunctionOct 7, 2022Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT DURING VITRECTOMY AN OPHTHALMIC SCRAPER WAS OPENED INCLINED TO THE LEFT SIDE, AND WAS NOT IN THE DESIRED POSITION IN THE FULLY OPEN STATE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15564263 ↗
• MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING POSTERIOR VITRECTOMY + EPIRETINAL MEMBRANE SURGERY THE OPHTHALMIC SCRAPER RING WAS BENT AND DID NOT ALLOW SCRAPING THE INTERNAL LIMITING MEMBRANE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15400913 ↗
• MalfunctionMar 2, 2021Break; Break

  A NURSE REPORTED THAT THE FLEX LOOP OF AN OPHTHALMIC MEMBRANE SCRAPER DEVICE BROKE WHILE INSIDE OF THE PATIENT'S EYE DURING SURGERY. 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 11399910 ↗