BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3022461 · Received March 22, 2013

    Report

    Report Number
    1119421-2013-00312
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    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
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED. ONE HAPTIC IS PULLED FROM THE OPTIC AND THE OPTIC IS CRACKED IN BOTH HAPTIC INSERTION AREAS. OTHER DAMGE WAS OBSERVED WHICH IS DUE TO THE LENS BEING REPLACED INCORRECTLY INTO THE LENS CASE FOR RETURN. SOLUTION AND BLOOD ARE DRIED ON THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. WHILE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE, OR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE CONDITION OF THE RETURNED SAMPLE (PRESENCE OF SURGICAL SOLUTION/BLOOD), THE OBSERVED DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INSERTION OF AN INTRAOCULAR LENS (IOL), THE HAPTIC WAS NOTED TO BE BROKEN AND THE LENS WAS UNSTABLE. THE SURGEON DECIDED TO EXPLANT THE LENS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119713 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MN60AC 12134918

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention