BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2890973 · Received December 21, 2012

    Report

    Report Number
    1119421-2012-01637
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    January 1, 2012
    Report Date
    December 1, 2012
    Manufacturer
    ALCON RESEARCH, LTD/ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

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

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS IS CAUSING CYLINDER INSTEAD OF CORRECTING IT. 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 SN6AT4 10961024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other