BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2202060 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00959
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HAS DEVELOPED EDEMA "BELOW EYE LENS" AND HAS BEEN TREATED WITH MEDICATION. SHE REPORTED THAT HER VISION IS WEAK. IN A FOLLOW UP WITH THE CONSUMER, SHE STATED THAT SHE RECENTLY UNDERWENT AN EXAMINATION AND IT WAS VERIFIED THAT WHAT SHE PRESENTED WAS NOT AN EDEMA, BUT ACTUALLY AN INFLAMMATION ON A MEMBRANE IN THE BACK OF THE EYE. SHE STATED THAT EVER SINCE THE IMPLANT SURGERY SHE HAS BEEN SEEING DARK SPOTS AND NOTICES THAT HER VISION IS WEAKER IN THE LOWER HALF OF HER LEFT EYE, COMPARING TO THE UPPER HALF. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other