Alcon Grieshaber REVOLUTION 705.44Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07612717064263), received between Mar 24, 2021 and Aug 28, 2026 — classified as 6 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (24 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495983 ↗
• MalfunctionJun 5, 2026Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS DID NOT OPEN. PATIENT DETAILS WERE UNKNOWN. PROCEDURE WAS COMPLETED WITH OTHER FORCEPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25409791 ↗
• MalfunctionOct 17, 2025Activation Problem; Activation Problem

  A PHYSICIAN REPORTED THAT DURING THE SURGERY THE TIP OF AN OPHTHALMIC FORCEPS DID NOT OPEN OR CLOSE PROPERLY INSIDE THE EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322557 ↗
• MalfunctionJul 2, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC FORCEPS TIP WAS NOT WORKING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22384463 ↗
• MalfunctionFeb 4, 2025Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS WAS FAILED TO OPEN. THE SURGERY WAS COMPLETED WITH ALTERNATIVE FORCEPS. 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 21303602 ↗
• MalfunctionOct 7, 2024Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT DURING A RETINAL PROCEDURE, THE OPHTHALMIC FORCEPS UNABLE TO OPEN OR CLOSE AND IT BECAME STUCK. THE PROCEDURE WAS COMPLETED BY USING NEW FORCEPS. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20392100 ↗
• MalfunctionAug 9, 2024Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT DURING SURGERY THE OPHTHALMIC FORCEPS COULD NOT BE CLAMPED PROPERLY IN THE OPEN STATE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PATIENT RETURNED SMOOTHLY TO THE WARD AFTER COMPLETING THE SURGERY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946627 ↗
• MalfunctionApr 1, 2024Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT THE OPHTHALMIC FORCEPS COULD NOT BE CLAMPED NORMALLY. THE SURGERY WAS COMPLETED AFTER REPLACING THE FORCEPS WITH ANOTHER ONE. THE PATIENT RETURNED TO THE WARD SMOOTHLY AFTER COMPLETING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010458 ↗
• MalfunctionDec 22, 2023Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT AN OPHTHALMIC FORCEPS COULD NOT BE CLOSED DURING A VITRECTOMY SURGERY AND PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388719 ↗
• MalfunctionNov 29, 2023Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT THE CLAWS OF AN OPHTHALMIC FORCEPS DID NOT CLOSE TO REMOVE THE MEMBRANE. SEVERAL ATTEMPTS WERE MADE BY THE MEDICAL SURGEON BUT ISSUE DID NOT RESOLVE. SURGERY WAS COMPLETED BY AN ALTERNATED FORCEPS WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229010 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE STATED THAT A PATIENT EXPERIENCED PEELING RELATED HEMORRHAGES USING AN OPHTHALMIC OPERATING SURGICAL FORCEPS. IT ALSO STATED THAT THE PEELING RELATED HEMORRHAGES ARE SIGNIFICANTLY HIGHER IN ANALOG MICROSCOPE GROUP THAN DIGITALLY ASSISTED VITREORETINAL SYSTEM GROUP .CURRENT PATIENT CONDITION IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17732484 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE STATED THAT A PATIENT EXPERIENCED PEELING RELATED HEMORRHAGES USING OPATHALMIC OPERATING SURGICAL FORCEPS. IT ALSO STATED THAT THE PEELING RELATED HEMORRHAGES SIGNIFICANTLY HIGHER IN ANALOG MICROSCOPE GROUP THAN DIGITALLY ASSISTED VITREORETINAL SYSTEM GROUP .CURRENT PATIENT CONDITION IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17732483 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE STATED THAT AFTER USING AN OPHTHALMIC FORCEPS, POSTOPERATIVE COMPLICATIONS OCCURRED WHICH INCLUDED RETINAL DETACHMENT, VITREOUS HEMORRHAGE ,HYPOTONY, OCULAR HYPERTENSION REQUIRING SUTURE. PATIENT CONDITION IS UNKNOWN.

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

  MAUDE report 17731539 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA CLINICAL STUDY THAT PATIENTS EXPERIENCED RETINAL TOUCH USING OPATHALMIC OPERATING SURGICAL FORCEPS. STUDY RESULTS SHOW THAT THE RETINAL TOUCH SIGNIFICANTLY THREE TIMES HIGHER DIGITALLY ASSISTED VITREORETINAL SYSTEM GROUP THAN ANALOG MICROSCOPE GROUP .CURRENT PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Retinal Tear

  MAUDE report 17720422 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED RETINAL TOUCH USING OPATHALMIC OPERATING SURGICAL FORCEPS. STUDY RESULTS SHOW THAT THE RETINAL TOUCH SIGNIFICANTLY LOWER IN ANALOG MICROSCOPE GROUP THAN DIGITALLY ASSISTED VITREORETINAL SYSTEM GROUP. CURRENT PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Retinal Tear

  MAUDE report 17719251 ↗
• MalfunctionJul 10, 2023Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC FORCEPS EXHIBITED POOR OPENING/CLOSING OF THE TIP. SURGERY WAS COMPLETED WITH AN ALTERNATE FORCEPS WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286792 ↗
• 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. THE PATIENT SYMPTOM WAS RESOLVED. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Retinal Tear

  MAUDE report 17151034 ↗
• MalfunctionMay 8, 2023Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC OPERATING FORCEPS TIP WAS NOT OPENING.THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885259 ↗
• MalfunctionApr 20, 2023Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC FORCEPS TIP DID NOT OPEN DURING INSERTION AT SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775825 ↗
• MalfunctionOct 28, 2022Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING A SURGERY AN OPHTHALMIC FORCEPS DID NOT OPEN. 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 15690410 ↗
• MalfunctionOct 27, 2022Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS DID NOT OPEN. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT EVENT OCCURRED DURING SURGERY AND PROCEDURE WAS VITRECTOMY -PELAGE-PHACOEMULSIFICATION -LASER INDIRECT OPHTHALMOSCOPE. THE SURGERY WAS COMPLETED WITH THE SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681694 ↗
• MalfunctionOct 27, 2022Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY PROCEDURE AN OPHTHALMIC FORCEPS TIP DID NOT RETRACT DURING PEELING OF MEMBRANE AND IT WAS STUCK AT CLOSE POSITION. THE SURGERY WAS COMPLETED. THERE IS NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678236 ↗
• MalfunctionOct 26, 2022Difficult to Insert; Difficult to Insert

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS WOULD NOT GO IN WHEN PLACING IN TROCAR DURING A SURGERY. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672173 ↗
• MalfunctionOct 18, 2022Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT AN OPHTHALMIC FORCEPS MOVES TO THE OPEN POSITION, THEN FAIL TO CLOSE TIGHTLY DURING SURGERY. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621865 ↗
• MalfunctionSep 28, 2022Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC FORCEPS TIP WAS STOPPED OPENING HALFWAY THROUGH DURING INSERTION. 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 15495679 ↗