BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCH DECEMET MEMBRANE KELLY

    MDR report key: 16865951 · Received May 3, 2023

    Report

    Report Number
    0001920664-2023-70046
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HNJ
    UDI-DI
    00757770416363
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE A ROOT CAUSE INTO THE COMPLAINT COULD NOT BE ESTABLISHED. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED BUT NOT YET RECEIVED. THIS INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621015 PUNCH DECEMET MEMBRANE KELLY PUNCH, CORNEO-SCLERAL HNJ BAUSCH + LOMB E2798 00757770416363

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention