BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2901131 · Received January 4, 2013

    Report

    Report Number
    1119421-2013-00003
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ALCON RESEARCH LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4918 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD./ HUNTINGTON SN60WF 12183024

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention