Bausch + Lomb SE5527MVBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770059758), received between Feb 24, 2023 and Feb 24, 2023 — classified as 2 malfunctions.

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

• MalfunctionFeb 24, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A 27G BI-BLADE CUTTER WAS NOT CUTTING CORRECTLY IF AT ALL. A SECOND 27G PACK WAS OPENED, WHERE AGAIN THE SAME HAPPENED. A THIRD PACK WAS OPENED AND PROCEDURE CONTINUED. NO PATIENT IMPACT. NO CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435180 ↗
• MalfunctionFeb 24, 2023Failure to Cut; Failure to Cut

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A 27G BI-BLADE CUTTER WAS NOT CUTTING CORRECTLY IF AT ALL. A SECOND 27G PACK WAS OPENED, WHERE AGAIN THE SAME HAPPENED. A THIRD PACK WAS OPENED AND PROCEDURE CONTINUED. NO PATIENT IMPACT. NO CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435164 ↗