BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1033363 · Received April 24, 2008

    Report

    Report Number
    1119421-2008-00269
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    January 1, 2007
    Report Date
    March 25, 2008
    Manufacturer
    ALCON RESEARCH LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT #. ADD'L INFO WAS REQUESTED 04/14/2008, 04/15/2008 AND 04/16/2008 BY PHONE, FAX AND MAIL. ADD'L INFO WAS REC'D 04/17/2008 BY PHONE. A COMPLETED QUESTIONAIRE HAS NOT BEEN REC'D. PT CODES: LABELED AND NOT LABELED. DEVICE CODE: NOT LABELED. THIS REPORT WAS MAILED TO FDA ON 04/24/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS, THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED BECAUSE THE PT REPORTED GLARE AND HALOS. FOLLOWING THE EXCHANGE, THE VISUAL DISTURBANCES HAVE RESOLVED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD / HUNTINGTON SN60T5 958864

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention