Bausch + Lomb E2798Recalls & reported problems
Bausch & Lomb Incorporated · PUNCH DECEMET MEMBRANE KELLY · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00757770416363), received between May 3, 2023 and May 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING PROCEDURE TO TREAT GLAUCOMA, THE TIP OF THE STORZ KELLY DECEMENT MEMBRANE PUNCH BROKE AND GOT LODGED IN THE PATIENT¿S LEFT EYE. THE PATIENT HAD THE BROKEN PIECE REMOVED FROM THE EYE BY A RETINA SPECIALIST THE SAME DAY AT ANOTHER FACILITY. THERE WAS NO ENLARGEMENT FROM THE SECONDARY SURGERY, AND IT IS UNKNOWN IF THE PATIENT HAD ANESTHESIA AT ANOTHER FACILITY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS STABLE AND IS HOME RECOVERING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16865951 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.