Bausch + Lomb BL5325WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00757770058129), received between Jan 6, 2017 and Feb 9, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryFeb 9, 2018Break; Break

  A REPORT FROM A USER FACILITY WAS RECEIVED STATING ONE TROCAR BROKE DURING SURGERY. THE 25 GAUGE TROCAR WAS INSERTED INTO THE SCLERA WITH A FLAT LAMELLAR AT 10:30, PLACED VERTICALLY FOR HALF OF THE DISTANCE AND THEN COMPLETELY INSERTED THROUGH THE SCLERA. THEREAFTER, AN UNSUCCESSFUL ATTEMPT WAS MADE TO INTRODUCE THE VITRECTOMY CUTTER INTO THE TROCAR. THE TROCAR WAS PULLED BACK SLIGHTLY WITH TWEEZERS TO ENABLE VISUAL INSPECTION (ONLY THE TROCAR HEAD WAS GRASPED), WHEREBY IT WAS OBSERVED THAT THE TROCAR WAS BROKEN AND ONLY THE SEGMENT WITH THE TROCAR HEAD COULD BE PULLED OUT OF THE SCLERA. THE REMAINING SEGMENT OF THE TROCAR REMAINED IN THE SCLERA. THEREFORE, IT WAS NECESSARY TO OPEN THE SCLERA SLIGHTLY TO REMOVE THE REMAINING SEGMENT. A CONVENTIONAL SCLEROTOMY WITH A LANCE WAS APPLIED AT THE SAME SITE.

  Patient problems: Eye Injury

  MAUDE report 7259099 ↗
• MalfunctionJan 6, 2017Failure to Cut; Failure to Cut

  THE USER FACILITY IN (B)(4) REPORTED THE INNER NEEDLE SOMETIMES STUCK AT OPEN POSITION SO THE CUTTER DID NOT CUT. IT WAS REPLACED WITH A STAND-ALONE CUTTER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6229135 ↗