BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASEREDGE 2.2 CLEAR CORNEAL KNIFE

    MDR report key: 7497953 · Received May 9, 2018

    Report

    Report Number
    0001920664-2018-00054
    Event Type
    Injury
    Date Received
    May 9, 2018
    Report Date
    April 9, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HNN
    UDI-DI
    20757770482522
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED E7600 KNIFE FROM LOT AAAX077 WAS RECEIVED. THE EXPIRATION DATE ON THE LABEL IS 2022-03-31. VISUAL INSPECTION FOUND THE BLADE DIRTY WITH PARTICULATES AND SALINE DENTRITES. THE TIP OF THE BLADE IS BENT/CURLED AND THERE ARE BURRS VISIBLE ALONG BOTH SIDES OF THE CUTTING EDGE OF THE TIP. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORDS FOR THE REPORTED FINISHED GOOD LOTS AND RAW MATERIAL COMPONENTS IDENTIFIED NO QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, INPROCESS OR FINAL INSPECTION PROCESSES. BASED UPON THE COMPLAINT TREND REVIEW, THE VOLUME OF COMPLAINTS IS WITHIN THE ACCEPTABLE CONTROL LIMITS AND NO COMPLAINT TREND IS OBSERVED. THE MANUFACTURING OF LASEREDGE KNIVES AT ANGIOTECH (SURGICAL SPECIALTIES) FOR BAUSCH + LOMB HAS BEEN DISCONTINUED. ANGIOTECH (SURGICAL SPECIALTIES) HAS HAD ON-GOING QUALITY PERFORMANCE ISSUES, THAT COULD NOT BE RESOLVED. ANGIOTECH (SURGICAL SPECIALTIES) CANNOT DEMONSTRATE SUSTAINED QUALITY PERFORMANCE AS A RESULT ANGIOTECH (SURGICAL SPECIALTIES) HAS BEEN DISQUALIFIED AS A SUPPLIER TO BAUSCH HEALTH AND ALL PRODUCT MANUFACTURED AFTER 12/4/17 HAS BEEN OUTSOURCED. THE BUSINESS HAS BEEN OUTSOURCED AS PER QCR 337906. THE SUPPLIER WILL CONTINUE TO BE NOTIFIED OF COMPLAINTS. A DULL BLADE/KNIFE OR DRAG OCCURRING DURING A PROCEDURE CAN BE THE RESULT OF A DAMAGED CUTTING EDGE, POINT OR APEX ON THE BLADE OR COULD BE DUE TO THE LACK OF SILICONE COATING ON THE BLADE COMPONENT ITSELF. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE KNIFE WAS FOUND TO BE DULL DURING A CATARACT SURGERY. THE FIRST INCISION WAS PERFORMED WITH DIFFICULTY. THE SURGEON NEEDED TO USE STRENGTH AND THEN OBTAINED A LARGE INCISION. TWO DAYS LATER THE PATIENT WAS RETURNED TO SURGERY DUE TO LACK OF TIGHTNESS OF THE INCISION. THE SURGEON USED ONE STITCH TO TIGHTEN THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340774 LASEREDGE 2.2 CLEAR CORNEAL KNIFE KNIFE, OPHTHALMIC HNN BAUSCH + LOMB E7600 AAAX077 20757770482522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention