BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3891769 · Received June 10, 2014

    Report

    Report Number
    9612169-2014-00066
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 5, 2014
    Report Date
    May 14, 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
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, SHE EXPERIENCED FLASHES, WAS NOT ABLE TO SEE IN THE LIGHT, HAD EYE DISCOMFORT, AND WAS UNABLE TO READ. THE SURGEON PERFORMED FLUORESCENCE ANGIOGRAPHY AND DETERMINED THE IOL'S TO BE CONTRIBUTING TO THESE SYMPTOMS. THE IOL'S REMAINED IMPLANTED. ADD'L INFO WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338829 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. AN60WF 21078558

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other MONARCH D CARTRIDGE AND RAYVISC