BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2202089 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00966
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE LENS AND THE DEVICE WERE RETURNED FOR EVAL. SOLUTION IS DRIED ON THE LENS. LENS DAMAGE WAS OBSERVED; THE HAPTICS ARE BENT AND THE OPTIC IS TORN/SPLIT/CRACKED, HAS SCRATCHES AND THE OPTIC EDGE IS CHIPPED/NICKED. THE DEVICE WAS RETURNED, THE NOZZLE IS STRESSED AND HAS A SMALL ANEURYSM. THE PLUNGER IS FULLY ADVANCED. IT IS UNK IF THE APPROVED VISCOELASTIC WAS USED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION BECAUSE THE LENS WAS NOT RETURNED "STUCK IN THE DEVICE." THE REPORTED COMPLAINT CAN OCCUR WHEN AN UNAPPROVED VISCOELASTIC IS USED. IT IS UNK IF THE APPROVED VISCOELASTIC WAS USED. DAMAGE OF THIS TYPE CAN ALSO OCCUR IF THE OPERATING ROOM TEMPERATURE IS TOO HIGH (GREATER THAN 23 DEGREES CELSIUS / 73.4 DEGREES FAHRENHEIT). DUE TO THE PRESENCE OF SURGICAL SOLUTION, THE OBSERVED DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THE FINDINGS, THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC CLINICAL LEADER REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL), THE PLUNGER STUCK. WHEN THE LENS WAS PUSHED IN, THE HAPTIC WAS NOTED TO BE DISPOSITIONED. THE LENS WAS REMOVED AND AN ANTERIOR VITRECTOMY PERFORMED. A DIFFERENT MODEL IOL WAS IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD./HUNTINGTON NA 10905105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention