BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2960326 · Received February 8, 2013

    Report

    Report Number
    1119421-2013-00119
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 10, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAS BEEN ONE SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OFFICE MANAGER REPORTED A PT WITH POOR NEAR VISION ONE MONTH FOLLOWING MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT. THE PT IS GIVING THE LENS SOMETIME AND IS SEEKING A SECOND OPINION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53117 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11028206

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other