BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2944967 · Received February 1, 2013

    Report

    Report Number
    1119421-2013-00099
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THER PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NOT OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY PHONE, FAX AND MAIL ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44406 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN6AT5 12180827

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other