BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6132843 · Received November 29, 2016

    Report

    Report Number
    1119421-2016-01656
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; IT REMAINS IMPLANTED. THE RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. ZIP CODE IS NOT INDICATED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL REPORTED THAT NINE DAYS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED IRIDOCYCLITIS. THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTIC/STEROID, TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY MEDICATION, AND POLYETHYLENE GLYCOL TOPICAL MEDICATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PRESCRIBED A TOPICAL ANTIBIOTIC/STEROID, A DIFFERENT TOPICAL STEROID, TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY MEDICATION, A TOPICAL ANTIBIOTIC AND HYDROXYL GLYCOSIDES TOPICAL MEDICATION THE DAY OF SURGERY. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT'S SYMPTOMS ARE CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782497 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT6 12389673

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other| R 5% IDOPHOR| A KIND OF HOME MADE PERFUSATE| EPINEPHRINE| HYDROXYL GLYCOSIDES EYE DROPS| LEVOFLOXACIN EYE DROPS| PRANOPROFEN EYE DROPS| PREDNISOLONE EYE DROPS| SODIUM HYALURONATE GELATIN| TOBRADEX EYE DROPS| UNSPECIFIED INTREPID AUTOSERT