IQ532 Laser Console 65500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125016258), received between Jan 26, 2026 and Jan 26, 2026 — 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.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT WAS REPORTED TO IRIDEX WHERE FIVE DAYS AFTER UNDERGOING TREATMENT FOR CENTRAL SEROUS RETINOPATHY USING THE IRIDEX LASER CONSOLE IQ532 WITH THE SLIT LAMP ADAPTER (SLA) AND THE SUBTHRESHOLD MICROPULSE LASER PHOTOCOAGULATION TECHNIQUE, A PATIENT EXPERIENCED WORSENED VISUAL ACUITY WITH A LARGE AREA OF COAGULATION AND SCOTOMA NOTED. IT SHOULD BE NOTED THAT THE PATIENT DEMONSTRATED IMPROVED VISUAL ACUITY IMMEDIATELY AFTER THE PROCEDURE WAS PERFORMED, WITH NO DEVICE MALFUNCTION NOR TREATMENT DEVIATION IMMEDIATELY FOLLOWING THE PROCEDURE. THE PHYSICIAN FURTHER REPORTED THAT THE PARAMETERS USED TO TREAT THE PATIENT WERE WITHIN THE RANGE AS DESCRIBED IN THE OPERATOR MANUAL OF THE DEVICE (300 MW MICROPULSE DUTY CYCLE, 300 MS DURATION, 145 INTERVALS, AND A TOTAL OF 102 LASER SHOTS ADMINISTERED USING A SINGLE-SHOT GRIS PATTERN). NO BLANCHING, COAGULATION, SUBCONJUNCTIVAL HEMORRHAGE, OR INTRAOPERATIVE BLEEDING WAS OBSERVED DURING EITHER THE TEST APPLICATIONS OR THE PRIMARY TREATMENT. NO PIGMENTED LESIONS OR AREAS OF INCREASED PIGMENTATION WERE PRESENT IN THE SURGICAL FIELD. AT THE ONE-WEEK POSTOPERATIVE VISIT, THE PATIENT'S VA HAD DECREASED TO 20/50, AND CLINICAL EXAMINATION REV

  Patient problems: Blurred Vision

  MAUDE report 24185371 ↗