BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2434552 · Received January 27, 2012

    Report

    Report Number
    9612169-2012-00007
    Event Type
    Injury
    Date Received
    January 27, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 29, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS AND DAMAGE WAS OBSERVED TO THE LENS. THE LENS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER . RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS: LENS RETURNED IN TWO (2) PIECES IN A NUMBER 79 (IW) LENS CASE. SOLUTION IS DRIED ON THE LENS. BOTH HAPTICS ARE BENT/DEFORMED AT THE GUSSET/ARM AREAS DUE TO THE CONDITION OF THE RETURNED SAMPLE. THE OPTIC IS TORN/SPLIT-POSSIBLY CUT. THE OPTIC EDGE IS TORN/SPLIT/CRACKED AND IS PARTIALLY ADHERED. UNABLE TO CONDUCT DIMENSIONAL TESTING DUE TO CONDITION OF RETURNED LENS. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE CONDITION OF THE RETURNED LENS, THE DAMAGE IS LIKELY CAUSED BY THE CUSTOMER AND IT IS UNLIKELY THAT THE DEVICE CONTRIBUTED TO THE EVENT. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2012 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE LENS WAS NOT CENTERED. IN A FOLLOW-UP, THE SURGICAL TECHNICIAN REPORTED THE LENS WAS EXCHANGED WITHOUT COMPLICATIONS AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21040162

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention