CONSTELLATION 8065750977Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657509775), received between Jun 23, 2023 and Dec 3, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Defective Device; Defective Device

  A NURSE REPORTED THAT DURING TESTING OF AN OPHTHALMIC LASER FOOTSWITCH, IT WAS FOUND THAT THE LASER ENERGY COULD NOT BE EXCITED NORMALLY WHEN IT WAS STEPPED ON. IT WAS ALSO REPORTED THAT THERE WAS NO DOWNWARD ARROW FEEDBACK ON THE LASER MAIN FOOT SWITCH ON THE SCREEN. THE SURGERY WAS NOT COMPLETED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829255 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT MIDDLE OF PARS PLAN VITRECTOMY LASER PROBE WAS CONNECTED ONTO THE MACHINE, A SYSTEM ADVISORY APPEARED SHOWING THAT THE LASER FOOT PEDAL IS NOT CONNECTED. SURGEON ATTEMPTED TO PRESS THE FOOT PEDAL BUT UNSUCCESSFUL THEN SURGEON PERFORMED CRYOTHERAPY INSTEAD OF LASER. PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT HARM.

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

  MAUDE report 17189679 ↗