BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1526955 · Received November 11, 2009

    Report

    Report Number
    1119421-2009-01070
    Event Type
    Injury
    Date Received
    November 11, 2009
    Date of Event
    April 1, 2009
    Report Date
    October 12, 2009
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/14/2009, 10/19/2009, AND 10/20/2009 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 10/19/2009. THIS REPORT WAS MAILED TO FDA ON: 1/11/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL ROTATED. ADDITIONALLY, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) ELEVATED AND WAS TREATED WITH MEDICATIONS, THE PATIENT'S VISUAL ACUITY DECREASED, AND MEDICATIONS WERE GIVEN FOR DRY EYES. IN A FOLLOW UP, THE SURGEON REPORTED THAT FOLLOWING TREATMENT FOR DRY EYES, THE PATIENT'S VISUAL ACUITY WAS UCVA 20/25 AND THE SURGEON WAS RECOMMENDING NO FURTHER SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH LTD / HUNTINGTON SN60T4 10805069

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention ALLOPURINOL| ATENOLOL| ASPIRIN| GLUCATROL| ZOFRAM