BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1832051 · Received September 3, 2010

    Report

    Report Number
    1119421-2010-00971
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 5, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    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 INFO WAS REQUESTED 08/06/2010 BY MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. PT (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNK" (NO INFO). PRODUCT PROBLEM(S): "LENS DID NOT LOOK RIGHT" (DEFECTIVE ITEM [IOL (INTRAOCULAR LENS) IMPLANT]); "LENS DID NOT LOAD PROPERLY" (DIFFICULT TO INSERT [IOL (INTRAOCULAR LENS) IMPLANT]). A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WOULD NOT LOAD PROPERLY AND THE SURGEON THOUGH THE LENS DID NOT LOOK RIGHT. PT IMPACT IS UNK. ADDITIONAL INFO 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 SN6AT5 10954850

    Patients

    Seq Age Sex Outcome Treatment
    1