BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2391839 · Received December 20, 2011

    Report

    Report Number
    1119421-2011-01553
    Event Type
    Injury
    Date Received
    December 20, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 21, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 11/21/2011, 11/23/2011, AND 12/13/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 12/13/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH NO CYLINDER CORRECTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE ALSO NOTED THE LENS HAD A SCRATCH IN THE CENTER OF THE VISUAL AXIS. IN A FOLLOW-UP, THE SURGEON REPORTED HE ROTATED THEN LENS SO THAT THE SCRATCH DID NOT AFFECT VISION. HE REPORTED PATIENT WAS SEEN AFTER THE ROTATION AND IS DOING "GOOD". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT7 12021557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention