BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4946641 · Received July 28, 2015

    Report

    Report Number
    9612169-2015-00563
    Event Type
    Injury
    Date Received
    July 28, 2015
    Report Date
    July 28, 2015
    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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS CORNEAL EDEMA POSTOPERATIVELY DAY ONE. IMMEDIATELY FOLLOWING THE PROCEDURE THERE WAS NO CORNEAL EDEMA NOTED. THE PATIENT WAS TREATED WITH STEROID DROPS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE 12 MANUFACTURER REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE NINTH LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490719 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21094184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention