Alcon Grieshaber REVOLUTION 25+ 705.45PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07612717070684), received between Jun 26, 2023 and Jun 27, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED VIA A CLINICAL STUDY THAT AFTER A VITRECTOMY SURGERY A PATIENT EXPERIENCED RETINAL SURFACE DAMAGE AND HEMORRHAGE. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Retinal Tear

  MAUDE report 17207794 ↗
• 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 ONE 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 17197594 ↗