Bausch + Lomb SE5525WVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20757770059687), received between May 9, 2023 and May 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 8, 2018Terminated

   The back cap separates from the body of the vitrectomy cutter.

   Z-3277-2018 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionMay 9, 2023Failure to Cut; Failure to Cut

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT 2 CUTTERS FROM THE SAME LOT WERE NOT CUTTING EFFICIENTLY WHILE THEY CONTINUED TO ASPIRATE. THERE WERE 2 PATIENTS INVOLVED, BUT NO MORE DISTINGUISHING INFORMATION IS AVAILABLE. THIS IS FOR THE FIRST PACK/CUTTER. THERE WAS AN INCREASE IN THE DURATION OF THE SURGERY OF 0 - 15 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899484 ↗
• MalfunctionMay 9, 2023Failure to Cut; Failure to Cut

  A USER FACILITY IN THE UNITED KINGDOM REPORTED THAT 2 CUTTERS FROM THE SAME LOT WERE NOT CUTTING EFFICIENTLY WHILE THEY CONTINUED TO ASPIRATE. THERE WERE 2 PATIENTS INVOLVED, BUT NO MORE DISTINGUISHING INFORMATION IS AVAILABLE. THIS IS FOR THE SECOND PACK/CUTTER. THERE WAS AN INCREASE IN THE DURATION OF THE SURGERY OF 0 - 15 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899463 ↗