IQ577 Laser Console 65600-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125016265), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.

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.

• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem

  IRIDEX BECAME AWARE OF THE COMPLAINT INVOLVING PATIENT EXPERIENCING MACULAR VISION LOSS AFTER TREATMENT. THE SURGEON REPORTED OBSERVING WHAT APPEARED TO BE A PLAQUE ON THE EYE AND REPORTED THAT HE DID NOT OBSERVE ANY TISSUE BURNS. FAILURE ANALYSIS WAS PERFORMED ON THE RETURNED CONSOLE AND DELIVERY DEVICE. THE RESULTS INDICATE THE SYSTEM IS FUNCTIONING WITHIN SPECIFICATIONS. NO MALFUNCTIONS OR ERRORS WERE OBSERVED THAT COULD CONTRIBUTE TO THIS OBSERVATION.

  Patient problems: Loss of Vision

  MAUDE report 10793256 ↗