BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2202082 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00934
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 7, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE DEVICE AND LENS WERE RETURNED. AN APPROVED SOLUTION WAS OBSERVED IN THE DEVICE. NO DAMAGE WAS OBSERVED TO THE DEVICE. LENS WAS RETURNED WITH SOLUTION AND A BENT HAPTIC. THE RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE APPEARS TO BE RELATED TO A FAILURE TO FOLLOW THE DFU. AN UNAPPROVED VISCOELASTIC WAS USED. VISCOSITY OF AN UNAPPROVED OVD MAY CONTRIBUTE TO UNDERFILL/OVERFILL, MISFOLDING OF THE TRAILING HAPTIC, LACK OF LUBRICITY OR OTHER UNPREDICTABLE OUTCOMES, WHICH CAN RESULT IN DAMAGE. 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 07/08/2011 AND 07/11/2011 BY FAX, MAIL AND PHONE. ADD'L INFO WAS RECEIVED 07/08/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED 07/15/2011. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MANAGER REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, AS THE SURGEON WAS ATTEMPTING TO INJECT THE IOL INTO THE PT'S EYE, THE IOL SHOT OUT ABRUPTLY, CAUSING THE NEED FOR A VITRECTOMY. THE LENS WAS REMOVED AND AN ALTERNATE LENS WAS PLACED DURING THE SAME PROCEDURE. FOLLOW UP INFO WAS RECEIVED FROM THE SURGEON, WHO REPORTED THAT THE EVENT CONTINUES. THE PT IS HEALING APPROPRIATELY, BUT HAS ONGOING RETINA RISKS. HE ALSO REPORTED THAT DURING THE SURGICAL PROCEDURE, THE WOUND WAS ENLARGED TO REMOVE THE INITIAL LENS. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD./HUNTINGTON NA 12012799

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PROVISC| DUOVISC