BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2141180 · Received June 22, 2011

    Report

    Report Number
    1119421-2011-00780
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. 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 THESE 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 ON 5/25/2011, 6/1/2011 AND 6/9/2011 BY FAX, MAIL AND PHONE. ADD'L INFO WAS RECEIVED ON 5/25/2011 AND 6/9/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 6/7/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PLUNGER FELT MORE RESISTANT AND "ENDED UP BREAKING THROUGH THE CAPSULE INTO THE VITREOUS". THE SURGEON WAS ABLE TO RETRIEVE THE LENS AND PERFORMED A VITRECTOMY. THE LENS WAS PLACED IN THE CAPSULAR BAG. F/U INFO WAS RECEIVED FROM THE SURGEON, WHO REPORTED THAT THE EVENT RESOLVED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 12012088

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention PROVISC