BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2195098 · Received July 14, 2011

    Report

    Report Number
    9612169-2011-00028
    Event Type
    Other
    Date Received
    July 14, 2011
    Date of Event
    April 11, 2011
    Report Date
    June 14, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ACTIONS: THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED OUTCOME (HYPEROPIA) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON INDICATED THAT CALCULATIONS WERE RECHECKED AND THE CAUSE OF THE OUTCOME REMAINS UNK. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21019912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other