Alcon 8065420120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380654201207), received between Nov 23, 2021 and May 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION HAS BEEN RECEIVED, CLARIFYING THAT DURING THE FINAL PHASE OF THE PROCEDURE, WHILE ATTEMPTING TO INCREASE INTRAOCULAR PRESSURE (IOP) THROUGH PARACENTESIS, THE CANNULA BECAME DISLODGED FROM THE SYRINGE DUE TO UNCERTAIN SECURING. THIS CAUSED THE CANNULA TO DETACH AND IMPACT THE IRIS CILIARY BODIES, RESULTING IN IRIS HEMORRHAGE, VITREOUS HEMORRHAGE, AND ZONULAR RUPTURE IN THE LEFT EYE. THE PATIENT WAS REFERRED TO A RETINAL SURGEON. THE HEMORRHAGE HAS SINCE CLEARED, AND THE PATIENT HAS BEEN DISCHARGED BY THE RETINAL SURGEON WITH A VISUAL ACUITY OF 20/30 IN THE LEFT EYE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vitreous Hemorrhage; Zonular Dehiscence

  MAUDE report 19284160 ↗
• InjuryMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CANNULA CAME OFF FROM THE SYRINGE AND THE LENS BEING DROPPED INTO THE POSTERIOR CHAMBER WITH A POSTERIOR CAPSULAR RUPTURE. THE PATIENT EXPERIENCED CHAMBER HEMORRHAGE, RETINAL TEAR. THE RETINAL SURGEON DID THE SULCUS FIXATION WITH INTRAOCULAR LENS RETRIEVAL AND LASER RETINAL TEAR REPAIRED TO THE RIGHT EYE. THE PROCEDURE WAS COMPLETED. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Retinal Tear; Rupture

  MAUDE report 19276142 ↗
• InjuryNov 23, 2021Connection Problem; Connection Problem

  A HEALTH PROFESSIONAL REPORTED THAT AN OPHTHALMIC CANNULA DISLODGED FROM SYRINGE DAMAGING POSTERIOR CHAMBER OF EYE WHILE SURGEON WAS HYDRATING WITH OPHTHALMIC IRRIGATING SOLUTION AT THE END OF CATARACT SURGERY. THE PATIENT REQUIRED ANTERIOR VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 12862541 ↗