BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 4173970 · Received October 1, 2014

    Report

    Report Number
    1119421-2014-00754
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ALCON RESEARCH, LTD., / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED WITH A HANDPIECE. THE LENS MODEL AND DIOPTER IS ONLY QUALIFIED FOR USE WITH APPROVED VISCOELASTIC. NOT ENOUGH INFORMATION WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ADDITIONAL INFORMATION INDICATED AN UNAPPROVED VISCOELASTIC WAS USED; THIS LENS/CARTRIDGE/HANDPIECE COMBINATION IS ONLY QUALIFIED FOR USE WITH APPROVED VISCOELASTIC. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL COORDINATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAS ROTATED. THE SURGEON HAS REPOSITIONED THE LENS ONCE APPROXIMATELY A MONTH FOLLOWING THE IMPLANT. THE LENS HAS ROTATED A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611653 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD., / HUNTINGTON SN6AT9 12188989

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention PROVISC| MONARCH D CARTRIDGE| MONARCH III HANDPIECE