Bausch + Lomb BL5112Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10757770057082), received between May 9, 2017 and May 24, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED OBSERVING GLITTERY METALLIC PARTICLES IN THE INCISION. A FEW OF THE PARTICLES WERE OBSERVED ON THE IRIS IN CLOSE PROXIMITY TO THE MAIN INCISION. IN ONE CASE THE PARTICLES WERE OBSERVED ON THE CONJUNCTIVA IN THE AREA OF THE MAIN INCISION. THERE WAS NO INJURY OR IMPACT TO THE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6588617 ↗
• MalfunctionMay 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED OBSERVING GLITTERY METALLIC PARTICLES IN THE INCISION. A FEW OF THE PARTICLES WERE OBSERVED ON THE IRIS IN CLOSE PROXIMITY TO THE MAIN INCISION. IN ONE CASE THE PARTICLES WERE OBSERVED ON THE CONJUNCTIVA IN THE AREA OF THE MAIN INCISION. THERE WAS NO INJURY OR IMPACT TO THE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6588456 ↗
• MalfunctionMay 24, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE USER FACILITY REPORTED OBSERVING GLITTERY METALLIC PARTICLES IN THE INCISION. A FEW OF THE PARTICLES WERE OBSERVED ON THE IRIS IN CLOSE PROXIMITY TO THE MAIN INCISION. IN ONE CASE THE PARTICLES WERE OBSERVED ON THE CONJUNCTIVA IN THE AREA OF THE MAIN INCISION. THERE WAS NO INJURY OR IMPACT TO THE PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6587923 ↗
• MalfunctionMay 9, 2017Inaccurate Flow Rate; Inaccurate Flow Rate

  A REPORT FROM A HEALTH FACILITY IN (B)(6) STATED THAT AFTER THE CALIBRATION OF THE SYSTEM AND AFTER PRESSING THE IRRIGATION DROPPER, THE IRRIGATION LINE DOES NOT MAINTAIN THE SALINE SOLUTION AND IT TURNS EMPTY. THIS CREATES SOME AIR BUBBLES THAT ARE INTRODUCED INTO THE POSTERIOR CHAMBER OF THE EYE. A NEW PACK WAS USED TO CONTINUE WITH THE SURGERY. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555393 ↗