BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIQ

    MDR report key: 2894790 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01593
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 23, 2012
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY PHONE, FAX, AND MAIL ON (B)(4) 2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED AN UNEXPECTED POSTOPERATIVE OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER WAS TOLD BY AN "OPTICIAN" THAT THE ASTIGMATISM WAS "TWO STEPS" WORSE THAN PRIOR TO SURGERY. THE CONSUMER ALSO REPORTED THAT DURING A POSTOPERATIVE FOLLOW-UP, THE SURGEON TOLD HIM THE MEASUREMENTS AND LOCATION OF THE LENS WERE CORRECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIQ INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10976730

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other