Synergetics 55.70.25PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20841305107094), received between Jun 15, 2022 and Jan 2, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fitting Problem” (2 reports).

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.

• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT DURING PROCEDURE THE SURGEON EXPERIENCED A VARIABLE UPTAKE ON THE LASER ON THE RETINA. SETTINGS WERE POWER 300, DURATION 100, INTERVAL 100. THE DURATION WAS RAISED TO 200, HOWEVER THE UPTAKE WAS STILL VARIABLE. AS A RESULT THE DOCTOR EXPERIENCED A HOT BURN THAT CAUSED A BREAK ON THE RETINA. A LASER RETINOPEXY WAS PERFORMED TO TREAT THE BREAK. THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATION.

  Patient problems: Eye Burn

  MAUDE report 18425924 ↗
• InjuryNov 16, 2023Fitting Problem; Fitting Problem

  THE SALES REP ON SITE FOR SURGERY REPORTED THE LASER PROBE GOT STUCK IN THE TROCAR CANNULA DURING LASER RETINOPEXY. THE LASER PROBE WAS TOO THICK TO GO THROUGH CANNULA. THE DOCTOR ENDED UP HAVING TO SUTURE THE SCLEROTOMY WITH A VICRYL 7.0 SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152268 ↗
• InjuryJun 15, 2022Fitting Problem; Fitting Problem

  THE SALES REP ON SITE FOR SURGERY REPORTED THE LASER PROBE PULLED THE TROCAR OUT OF THE PATIENTS EYE. THE SURGERY WAS DELAYED MAYBE 10 MINUTES AND A SUTURE WAS REQUIRED TO CLOSE THE WOUND. NO ADDITIONAL ANESTHESIA REQUIRED. THEY WERE ABLE TO COMPLETE THE SURGERY WITH NO ADDITIONAL PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14699533 ↗