BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3214039 · Received July 3, 2013

    Report

    Report Number
    1119421-2013-00733
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 9, 2013
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LENS WAS RETURNED. HAPTIC AND OPTIC DAMAGE WAS OBSERVED. SOLUTION IS OBSERVED 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. WHILE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE, BUT THIS WAS NOT DISCOVERED UNTIL AFTER THE IMPLANTATION. THE PATIENT CALLED IN AND REPORTED A PROBLEM. UPON EXAMINATION, THE HAPTIC WAS NOTED TO BE BROKEN. THE LENS WAS EXCHANGED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305166 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention