IQ577 Laser Console 65600-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125016616), received between May 22, 2019 and May 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IRIDEX RECEIVED A REPORT WHICH ALLEGED THAT DURING A PROCEDURE A CONSOLE (IQ532) WAS SET IN MICROPULSE MODE HOWEVER FIRED IN CONTINUOUS WAVE MODE. THIS RESULTED IN A MACULAR BURN. IN CONJUNCTION WITH THE IQ532 CONSOLE A SLITLAMP ADAPTER (SLA), SERIAL NUMBER (B)(4), WAS USED AS A DELIVERY DEVICE.

  Patient problems: Visual Impairment

  MAUDE report 8633094 ↗