Alcon Grieshaber REVOLUTION 25+ 705.44PRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 07612717070622), received between Mar 9, 2021 and Sep 22, 2026 — classified as 1 injury, 92 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (65 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  A government agency reported that during vitreoretinal procedure, an ophthalmic forceps failed to spring back and could not perform normal grasping and release functions. Use of the forceps was immediately discontinued. The forceps were replaced with a new internal limiting membrane (ILM) forceps, and the procedure was completed on the same day. Patient impact has not been provided. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50853263 ↗
• MalfunctionSep 18, 2026Activation Problem

  A customer reported that during retinal surgery an ophthalmic forceps disassembled while the surgeon was peeling the internal limiting membrane. Parts of the forceps fell onto the retina and successfully retrieved the detached parts from the retina. The forceps were replaced with another unit. The surgery was completed on the same day. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818040 ↗
• MalfunctionApr 20, 2026Activation Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY PROCEDURE, AFTER THE MEMBRANE WAS CUT, THE OPHTHALMIC FORCEPS REMAINED LOCKED IN THE CLOSED POSITION, MAKING THE INSTRUMENT IMPOSSIBLE TO USE. AS A RESULT, IT BECAME DIFFICULT TO PEEL THE EPIRETINAL MEMBRANE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE DEVICE. THE PATIENT IMPACT HAS NOT BEEN PROVIDED. THIS COMPLAINT IS RELATED TO THE FIRST DEVICE USED.

  Patient problems: Insufficient Information

  MAUDE report 24922568 ↗
• MalfunctionApr 10, 2026Activation Problem

  A NURSE REPORTED THAT AN OPHTHALMIC FORCEPS WAS FOUND IN THE CLOSED POSITION UPON OPENING THE NEW PACKAGE AND DID NOT FUNCTION. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24843946 ↗
• MalfunctionFeb 27, 2026Activation Failure

  A PHYSICIAN REPORTED THAT, DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS TIPS COULD NOT BE OPENED TO A WIDE ANGLE AND COULD NOT USE SMOOTHLY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE FORCEPS WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468841 ↗
• MalfunctionJan 14, 2026Activation Problem

  THE PHYSICIAN REPORTED THAT DURING SURGERY OPHTHALMIC FORCEPS TIP WAS CLOSED AND STUCK. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 24065326 ↗
• MalfunctionJan 7, 2026Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS GOT STUCK RESULTING IN IMPROPER OPENING. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE FORCEPS. DETAILS OF PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTING THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988610 ↗
• MalfunctionJan 2, 2026Break

  A CUSTOMER REPORTED THAT DURING A POSTERIOR VITRECTOMY WITH RETINOPEXY AND MEMBRANE PEELING SURGERY ON THE LEFT EYE, THE TIP OF THE OPHTHALMIC FORCEPS BECAME STUCK, AND THE GRIPPING MECHANISM THAT OPENS AND CLOSES APPEARED TO HAVE BROKEN. THE PATIENT HAD TO WAIT WHILE THE DEVICE WAS REPLACED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE FORCEPS, AND THE PATIENT¿S CONDITION HAS BEEN IMPROVING. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 23941930 ↗
• MalfunctionNov 25, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC FORCEPS MALFUNCTIONED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ALTERNATIVE FORCEPS, WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642506 ↗
• MalfunctionNov 12, 2025Break; Break

  A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC FORCEPS WAS FOUND BROKEN. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530056 ↗
• MalfunctionNov 9, 2025Activation Problem; Activation Problem

  A NURSE REPORTED THAT THE GRASPING END OF AN OPHTHALMIC FORCEPS COULD NOT BE CLOSED DURING A VITRECTOMY PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507440 ↗
• MalfunctionOct 17, 2025Activation Problem; Activation Problem

  A CUSTOMER REPORTED THAT, DURING VITRECTOMY SURGERY AN OPHTHALMIC FORCEPS DID NOT WORK CORRECTLY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY OPENING NEW FORCEPS WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323671 ↗
• MalfunctionAug 28, 2025Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS CANNOT BE OPENED. THE SURGERY WAS COMPLETED AFTER REPLACEMENT WITH ALTERNATIVE PRODUCT. NO IMPACT ON PATIENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22910330 ↗
• MalfunctionJul 31, 2025Activation Failure; Activation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VITRECTOMY PROCEDURE, THE RETRACTION MECHANISM IN THE OPHTHALMIC FORCEPS WAS STUCK AND DID NOT WORK DURING FIRST USE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE FORCEPS, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672962 ↗
• MalfunctionJul 28, 2025Difficult to Open or Close; Difficult to Open or Close

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC FORCEPS WERE ENTRAPPED AND COULD NOT CLOSE PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 22629984 ↗
• MalfunctionJul 15, 2025Activation Problem; Activation Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS DID NOT CLOSE PROPERLY DURING MACULAR PUCKER PEEL SURGERY. SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING A PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506642 ↗
• MalfunctionJun 26, 2025Activation Problem; Activation Problem

  A NURSE REPORTED THAT AN OPHTHALMIC FORCEPS OPEN ONLY ONCE AND DID NOT OPEN AGAIN DURING VITRECTOMY SURGERY. 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 22340359 ↗
• MalfunctionMay 27, 2025Difficult to Open or Close; Difficult to Open or Close

  A GOVERNMENT AGENCY REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC FORCEPS WAS UNABLE TO FULLY CLOSE. THE SURGERY WAS COMPLETED POST REPLACING THEM WITH NEW ONES WITH NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088188 ↗
• MalfunctionMay 23, 2025Break; Break

  A CUSTOMER REPORTED THAT DURING MEMBRANE PEEL WITH VITRECTOMY SURGERY INTERNAL LIMITING MEMBRANE (ILM) FORCEPS WAS NOT ABLE TO GRAB TISSUE TO PEEL AND IT WAS STUCK IN THE CLOSED POSITION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER ILM FORCEPS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077130 ↗
• MalfunctionMay 15, 2025Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS WOULD NOT OPEN AND CLOSE COMPLETELY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. NO IMPACT ON PATIENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22026093 ↗
• MalfunctionApr 16, 2025Activation Problem; Activation Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY SURGERY IN AN OPHTHALMIC FORCEPS , GRASPING FAILURE OCCURRED AND IT CLOSED AND DID NOT OPEN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE FORCEPS AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21847903 ↗
• MalfunctionApr 11, 2025Activation Problem; Activation Problem

  A PHYSICIAN REPORTED THAT DURING SURGERY THE TIP OF THE OPHTHALMIC FORCEPS DID NOT OPEN AND JUST REMAINED CLOSED. THERE WAS NO PATIENT HARM. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21824199 ↗
• MalfunctionApr 7, 2025Break; Activation Problem; Break; Activation Problem

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY TIP OF AN OPHTHALMIC FORCEPS STOPPED OPENING. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM AS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785717 ↗
• MalfunctionMar 31, 2025Activation Problem; Activation Problem

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY OPHTHALMIC FORCEPS HEAD CANNOT BE CLOSED AND WAS UNABLE TO GRAB THE MACULAR MEMBRANE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE FORCEPS AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734799 ↗
• MalfunctionMar 18, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS GOT STUCK CLOSED. THE SURGERY WAS CONTINUED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632151 ↗