BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1940496 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01391
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 17, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. THE PRODUCT WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. BOTH HAPTICS WERE BENT-DISTAL AREA. THE OPTIC HAD SCRATCHES-REJECTABLE. THE LENS FOLDED WITH NO ABNORMALITIES. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MFG RELATED. PRODUCT HISTORY RECORDS WERE REVIEW AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 11/18/2010 AND 12/09/2010 BY MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT FOLD CORRECTLY. 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 SN6AT3 10940097

    Patients

    Seq Age Sex Outcome Treatment
    1