BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2195297 · Received June 30, 2011

    Report

    Report Number
    9612169-2011-00025
    Event Type
    Other
    Date Received
    June 30, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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 MANUFACTURING DOCUMENTATION. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. NOT ENOUGH INFORMATION PROVIDED BY THE CUSTOMER TO CONDUCT A REVIEW OF THE LOT AND BATCH HISTORY RECORDS. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. FINAL COMMENTS: BASED ON OUR CURRENT TRENDS, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THE REPORTER DID NOT PROVIDE ANY SURGEON CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SEES WELL AND THEN THE VISION GETS BLURRY. THE CONSUMER REPORTED THAT HER SURGEON TOLD HER THAT HE FELT THAT AFTER CATARACT SURGERY ON THE FELLOW EYE, EVERYTHING WOULD BE FINE. THE REPORTER DID NOT PROVIDE ANY SURGEON CONTACT INFORMATION; THEREFORE, FOLLOW UP WAS NOT ABLE TO BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other