BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1120780 · Received August 15, 2008

    Report

    Report Number
    1119421-2008-00595
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    May 19, 2008
    Report Date
    July 18, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. 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 VIA PHONE ON 07/18/2008, 07/21/2008, 07/28/2008, 08/04/2008, AND 08/11/2008 AND VIA FAX AND MAIL ON 07/22/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED HAVING BLURRY NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE ALSO REPORTED EXPERIENCING EYE PAIN, FOREIGN BODY SENSATION, AND A FEELING OF EYE STRAIN. ADDITIONAL 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 SN60T4 10805056

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other