BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1172775 · Received September 19, 2008

    Report

    Report Number
    1119421-2008-00729
    Event Type
    Other
    Date Received
    September 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 20, 2008
    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
    TX, 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 EMT RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/25/2008 AND 08/28/2008 BY FAX, MAIL, AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/29/2008.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD./ HUNTINGTON SN60T3 10729267

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other NEVANAC| VIGAMOX| PRENISOLONE ACETATE