UNITY TETRASPOT 00380650002365Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650002365), received between Jun 30, 2025 and Mar 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Firing Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE STOPPED PRODUCING SPOTS. THE SURGEON WAS USING A SINGLE SPOT PROBE WHEN IT STOPPED WORKING. A NEW PROBE WAS INSTALLED AND WORKED PERFECTLY. DETAILS OF THE PROCEDURE COMPLETION WERE NOT PROVIDED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712426 ↗
• MalfunctionJul 29, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY PROCEDURE, AN OPHTHALMIC LASER PROBE WAS ABLE TO BE EMITTED WITH FOUR SPOTS, BUT WHEN SWITCHED TO ONE SPOT, THE SURGICAL AREA WAS NOT CAUTERIZED. IT WAS UNCLEAR WHETHER THE LASER WAS EMITTED OR NOT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645826 ↗
• MalfunctionJun 30, 2025Smoking; Failure to Fire; Smoking; Failure to Fire

  A CUSTOMER REPORTED THAT DURING SURGERY MULTI SPOT LASER PROBE FAILED TO FIRE LASER AND SMOKE WAS OBSERVED. THE CASE WAS COMPLETED BY PROVIDING A NEW LASER PROBE FOR THE SURGEON. THERE WERE NO PATIENT INJURIES THAT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356556 ↗