Alcon, Infiniti 8065741080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657410804), received between Dec 8, 2021 and May 17, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inability to Irrigate” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED CORNEAL EDEMA APPEARED ON THE FIRST DAY AFTER A CATARACT SURGERY, THE PATIENT REPORTED THAT HIS VISION WAS UNCLEAR. THE PATIENT WAS TREATED WITH ANTIBIOTIC DROPS. THE SYMPTOMS OF CORNEAL EDEMA WERE RELIEVED AFTER MEDICATION, AND VISION WAS IMPROVED.

  Patient problems: Corneal Edema

  MAUDE report 14425020 ↗
• MalfunctionDec 8, 2021Inability to Irrigate; Inability to Irrigate

  A NURSE REPORTED THE FLUID COULD NOT PASS THROUGH THE FLUIDICS MANAGEMENT SYSTEM (FMS) DURING THE CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER A REPLACEMENT WAS USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962817 ↗