OcuLight TX Laser Console 32000-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125016494), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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.

• InjuryDec 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IRIDEX BECAME AWARE OF AN INCIDENT INVOLVING OCULIGHT TX LASER CONSOLE AND SLIT LAMP ADAPTER (SLA) WERE THE LASER OUTPUT WAS TOO HIGH AND CAUSED BLEEDING AT PATIENT'S EYE. THE TREATMENT SETTING AND TECHNIQUE USED DURING THE PROCEDURE WAS SET TO 200MW. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL HISTORY. THE PATIENT WAS UNAWARE OF THE BLEEDING AND THE DOCTOR IMMEDIATELY STOPPED THE TREATMENT UPON REALIZING THERE WAS A MINOR BLEED. THE PATIENT WAS GIVEN AN EYEDROP AFTER THE PROCEDURE AND DID NOT REPORT ANY FURTHER COMPLICATIONS. THE UNIT WAS NOT RETURNED FOR EVALUATION, HOWEVER UPON SERVICE INVESTIGATION IT WAS DETERMINED THAT THE ISSUE WAS CAUSED BY A BURNT FIBER. FIBER REPLACEMENT WAS SENT TO THE CUSTOMER. THE REPORTED EVENT DUE TO A BURNT FIBER IS A KNOWN RISK/FAILURE MODE. THE OCULIGHT TX CONSOLE OPERATOR MANUAL CLEARLY INSTRUCTS ON THE PHYSICIAN VERIFY THAT THE FIBER-OPTIC CONNECTOR IS NOT DAMAGED BEFORE USE AS WELL AS THE PRE-SET PARAMETER SETTINGS BEGINNING AT LOW POWER WITH SHORT DURATION EXPOSURES, THE SURGEON SHOULD NOTE THE SURGICAL EFFECT AND INCREASE POWER, POWER DENSITY, OR EXPOSURE DURATION UNTIL THE DESIRED SURGICAL EFFECT IS OBTAINED. THE OPERATIVE NEEDS OF EACH

  Patient problems: Eye Injury

  MAUDE report 23830744 ↗