BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2214147 · Received July 22, 2011

    Report

    Report Number
    9612169-2011-00033
    Event Type
    Other
    Date Received
    July 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 23, 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS DAYLIGHT VISION IMPROVED; HOWEVER, HIS LOW LIGHT AND NIGHT VISION HAS BEEN POOR AND HE IS UNABLE TO DRIVE AT NIGHT SINCE THE SURGERY. THE SURGERY WAS PERFORMED IN 2009. IN A F/U, THE CONSUMER FURTHER REPORTED THAT HE HAS DISCUSSED HIS ISSUES WITH HIS SURGEON WHO DOES NOT KNOW THE REASON FOR HIS MISTY, CLOUDY VISION. THE CONSUMER REPORTED THAT, AS FAR AS HE IS AWARE, THERE IS NO EVIDENCE OF [OCULAR] DISEASE OR OPACITY AND HIS EYES ARE "PERFECTLY HEALTHY." HE REPORTED HE HAS HAD FIVE EYE TESTS AT DIFFERENT OPTICIANS SINCE THE IMPLANT PROCEDURE, ALL GIVING SIMILAR RESULTS. ADD'L INFO HAS BEEN REQUESTED FROM THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 20802521

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other