PASCAL Synthesis, 577nm PASCAL Synthesis 577Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813125015534), received between May 15, 2025 and May 15, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K123542); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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 15, 2025Mechanical Problem; Mechanical Problem

  ON (B)(6) 2025, IRIDEX BECAME AWARE OF AN INCIDENT THAT OCCURRED AT THE MASS EYE & EAR INFIRMARY THAT INVOLVED A PASCAL SYNTHESIS OPHTHALMIC LASER SYSTEM, WHICH IS A LASER SYSTEM INTEGRATED WITH A TABLE. IT WAS REPORTED THAT WHILE ATTEMPTING TO MOVE THE TABLE WHEN THE LASER WAS NOT IN USE, THE SUPPORT FOR ONE OF THE TABLE LEGS WAS COMPROMISED AND THE TABLE FELL. IT SHOULD BE NOTED THAT THE TABLE FALL OCCURRED WHEN THE PRODUCT WAS NOT IN USE AND IS UNRELATED TO THE DELIVERY OF LASER ENERGY. THE INITIAL REPORT DID NOT INDICATE THAT THE TABLE FALL RESULTED IN AN INJURY. IN SUBSEQUENT FOLLOW UP COMMUNICATIONS WITH THE SITE, IT WAS LEARNED THAT THE TABLE FELL ON AN EMPLOYEE'S FOOT RESULTING IN EMPLOYEE INJURY, SPECIFICALLY A FRACTURED RIGHT HALLUX. NO PATIENT WAS PRESENT, THE LASER SYSTEM WAS NOT IN USE AT THE TIME OF THE EVENT, AND THE PRODUCT WAS IN TRANSIT FROM THE PROPERTY'S STORAGE ROOM. IN A REVIEW OF PRODUCT RECORDS, IT WAS DETERMINED THAT THE EVENT OCCURRED ON AN 8-YEAR-OLD PRODUCT THAT WAS BEYOND PRODUCT WARRANTY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22029782 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123542. One submission often covers many models, so check the product and lot details in each record.

• Z-2405-2016 · Jul 15, 2016 · Terminated
  Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.