BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1773840 · Received July 23, 2010

    Report

    Report Number
    1119421-2010-00852
    Event Type
    Malfunction
    Date Received
    July 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/25/2010 AND 07/19/2010 BY MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/19/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT: "NO HARM" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM: "SCRATCH" (SCRATCHED MATERIAL [IOL (INTRAOCULAR LENS) IMPLANT]). A NURSE REPORTED THAT THE SURGEON NOTICED A SCRATCH ON AN INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. IN A FOLLOW-UP, IT WAS REPORTED THAT THE IOL WAS NOT IMPLANTED, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10976726

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR