Alcon Grieshaber REVOLUTION 705.47Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07612717070752), received between Jun 26, 2023 and Mar 5, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY SURGERY, THE TIP OF THE FORCEPS HAD POOR OPENING AND CLOSING AND POOR GRASPING, AND OPENING AND CLOSING WAS STIFF DURING INSERTION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835972 ↗
• 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 17201751 ↗
• 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 TWO OF ELEVEN REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC FORCEPS.

  Patient problems: Retinal Detachment; Retinal Tear; Visual Impairment

  MAUDE report 17200007 ↗
• 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 PRESERVE CURRENT VISION WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCTS A PATIENT EXPERIENCED DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS WERE IMPROVING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS SECOND OF THREE REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC FORCEPS.

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

  MAUDE report 17197595 ↗
• 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 SECOND OF ELEVEN REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC FORCEPS.

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

  MAUDE report 17196832 ↗