BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25G BI-B POSTERIOR ELITE W WF

    MDR report key: 12425450 · Received September 3, 2021

    Report

    Report Number
    0001920664-2021-00105
    Event Type
    Injury
    Date Received
    September 3, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BAUSCH + LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K170052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, SO UNABLE TO INVESTIGATE FOR ROOT CAUSE. THE REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR ASSEMBLY OF THE FINISHED SE5425WB LOT W8735 SHOWED THE PRODUCT WAS PROPERLY MANUFACTURED, TESTED, AND MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE MANUFACTURE OF THE LIGHT PIPE PART # (B)(4) SHOWED THAT FOR EACH OF THE SIX LOTS MANUFACTURED AND USED IN LOT W8735 (LIGHT PIPE LOTS M0034-152, -203, -204, -345, -462, AND -463) THAT THE RECORDS WERE ACCEPTABLE, ALL FUNCTIONAL TESTING AND VISUAL INSPECTION WAS PERFORMED PER PROCEDURE, NO NEGATIVE QUALITY PATTERNS WERE REVIEWED AND NO NON-CONFORMANCES ARE ASSOCIATED WITH THE DEVICE HISTORY RECORDS. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED. (SEE RELATED REPORTS 0001920664-2021-00106, 0001920664-2021-00107, 0001920664-2021-00108).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE TIP OF THE LIGHT PIPE BROKE AFTER A FEW SECONDS OF USE. THE TIP DID NOT BREAK IN THE PATIENTS' EYE AND NO SUTURES WERE REQUIRED. THE SURGERY PROCEEDED WITH A DIFFERENT PACK. THE SURGERY WAS EXTENDED BY 10 MINUTES AND THE ANESTHESIA WAS PROLONGED. ASIDE FROM THE DELAY IN SURGERY, THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318187 25G BI-B POSTERIOR ELITE W WF UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB, INC. SE5425WVB 222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention