Alcon Grieshaber REVOLUTION 705.52Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07612717064638), received between Jun 8, 2021 and Sep 13, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2024Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC SCISSOR REMAINED OPEN POSITION AND COULD NOT REMOVE IT THROUGH TROCAR OR CANNULA WHERE THE ENTRY POINT WAS ENLARGED AND THE SCISSORS WERE REMOVED FROM THE PATIENT EYE POST WHICH SUTURES WERE USED TO CLOSE THE WOUND. IT WAS CLEAR THAT THE PATIENT HAD NO IMPACT AND WAS RECOVERED WITH NO RESIDUAL EFFECTS AND ALSO THE SUTURES WERE REMOVED.

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

  MAUDE report 20210205 ↗
• MalfunctionJul 12, 2024Break; Break

  A NURSE REPORTED THAT THE TIP OF THE SCISSOR WAS DAMAGED UPON OPENING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730392 ↗
• MalfunctionMar 26, 2024Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC BLADE WAS BROKEN DURING SURGERY. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING VITRECTOMY SURGERY THE KNIFE WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977146 ↗
• MalfunctionSep 25, 2023Break; Break

  A CUSTOMER REPORTED THAT OPHTHALMIC SCISSORS BROKE IN THE PATIENT¿S LEFT EYE DURING THE MIDDLE OF THE RETINAL PROCEDURE. THE SCISSOR BLADE BROKE AWAY FROM THE HANDPIECE INTO THE PATIENT¿S EYE. THE PHYSICIAN WAS ABLE TO LOCATE THE BROKEN BLADE IN THE PATIENT¿S EYE AND REMOVED WITH FORCEPS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806517 ↗
• MalfunctionSep 13, 2023Dull, Blunt; Dull, Blunt

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SCISSOR WAS FOUND TO BE SHARPLESS AND HARD TO USE. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736800 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC FORCEPS AND HANDPIECE A 80 YEARS FEMALE PATIENT EXPERIENCED RETINAL DETACHMENT, DECREASED VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND UNKNOWN INTERVENTION WAS GIVEN. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment; Visual Impairment

  MAUDE report 17201750 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCT A PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS ARE STILL CONTINUING . NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS THREE OF ELEVEN REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC SCISSORS.

  Patient problems: Retinal Detachment; Retinal Tear; Visual Impairment

  MAUDE report 17200014 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY INCLUDING MEMBRANE PEELING AND REATTACHMENT OF RETINA TO IMPROVE CURRENT VISION WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCTS A PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS WERE CONTINUING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS THIRD OF ELEVEN REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC SCISSORS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment; Retinal Tear

  MAUDE report 17196831 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC DISPOSABLE PRODUCT A PATIENT EXPERIENCED RETINAL TEAR REQUIRING SURGICAL INTERVENTION. THE PATIENT SYMPTOM WAS RESOLVED. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Retinal Tear

  MAUDE report 17150961 ↗
• MalfunctionApr 8, 2022Break; Break

  A NURSE REPORTED THAT DURING A VITRECTOMY PROCEDURE AN OPHTHALMIC SCISSOR TIP WAS BROKEN INSIDE THE PATIENT'S EYE. THE SURGERY WAS COMPLETED REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14050444 ↗
• MalfunctionMar 31, 2022Break; Break

  A NURSE REPORTED THAT DURING A SURGERY AN OPHTHALMIC MICRO SCISSOR BLADE WAS BROKEN. PROCEDURE COMPLETED USING ANOTHER SCISSOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966456 ↗
• MalfunctionDec 7, 2021Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC SCISSOR CUTTING EDGE WERE MISALIGNED AND WOULD NOT CUT DURING SURGERY. THE PROCEDURE COMPLETED AFTER USING NEW SCISSORS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953243 ↗
• MalfunctionJun 8, 2021Break; Break

  A NURSE REPORTED THAT A TIP OF SCISSORS WAS BROKEN IN THE PATIENT'S EYE DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING THE SCISSOR WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958558 ↗