BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3841040 · Received May 14, 2014

    Report

    Report Number
    9612169-2014-00055
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 17, 2014
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, LENS REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. BASED ON RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HRS FOLLOWING AN INTRAOCULAR (IOL) IMPLANT PROCEDURE, SHE NOTICED A WHILE CLOUD OVER HER VISION. THE SURGEON ADJUSTED HER POSTOPERATIVE MEDICATIONS, AND DAYS LATER THE CLOUD STARTED LIFTING. THE CONSUMER ALSO REPORTED THAT SHE HAS EXPERIENCED VERTIGO, PHOTOPHOBIA, DEPTH PERCEPTION ISSUES AND THE COLOR OF THE SKY WAS LAVENDER FOLLOWING THE IOL IMPLANT PROCEDURE. THE CONSUMER REPORTED THE SURGEON MEASURED HER OPERATED EYE TO BE SET FOR NEAR VISION AND HER FOLLOW EYE HAS A CATARACT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288002 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21094210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other