BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 1234095 · Received November 4, 2008

    Report

    Report Number
    1119421-2008-00870
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Report Date
    October 5, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). THS REPORT WAS TO FDA ON (B)(6) 2008. THE MFR INTERNAL REF NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE FOUND DOTS ON THE OPTIC OF AN INTRAOCULAR LENS (IOL). THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGON SN60T3 10811277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA