Accurus, Alcon 8065803650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380658036508), received between Jan 8, 2022 and Jan 8, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Prime” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2022Failure to Prime; Suction Failure; Failure to Prime; Suction Failure

  A NURSE REPORTED THAT AN OPHTHALMIC OPERATING CONSOLE PRESENTED NO ASPIRATION DURING A VITRECTOMY PROCEDURE. THE VITRECTOMY PROBE WAS CHANGED BUT THE CONSOLE DID NOT PRIME. THE CONSOLE RESTARTED AND IT DID NOT PRIME AGAIN. THE SURGERY WAS COMPLETED AFTER REPLACING THE CONSOLE WITH ANOTHER ONE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE TIME. THE PATIENT EXPERIENCED SUPRACHOROIDAL HEMORRHAGE AS THE RESULT OF THE DELAY. THE PATIENT'S SYMPTOMS ARE RESOLVING. ADDITIONAL INFORMATION HAS BEEN RECEIVED CLARIFYING THAT THE SCHEDULED PROCEDURE WAS "PHACO CATARACT EXTRACTION AND INTRAOCULAR LENS IMPLANT" SURGERY. THE PATIENT WAS TRANSFERRED TO NEIGHBOR FACILITY AND UNDERWENT VITREO-RETINAL PROCEDURE FOR THE SUPRACHOROIDAL HEMORRHAGE. THE PATIENT IS MAKING A PROMISING INITIAL RECOVERY. THIS IS SECOND OF TWO REPORTS FOR THIS REPORTED EVENT.

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

  MAUDE report 13200829 ↗