BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1960239 · Received January 6, 2011

    Report

    Report Number
    1119421-2010-01501
    Event Type
    Other
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO MALFUNCTION CAN BE DETERMINED AT THIS TIME. SAMPLE IS PENDING RECEIPT. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. IT WILL BE REASSESSED UPON SAMPLE RECEIPT. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 12/13/2010, 12/16/2010 AND 12/17/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY DUE TO THE IOL BEING ROTATED OFF AXIS. ADDITIONAL INFO 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 SN6AT5 10976637

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other