BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1266579 · Received December 17, 2008

    Report

    Report Number
    1119421-2008-01014
    Event Type
    Injury
    Date Received
    December 17, 2008
    Date of Event
    June 1, 2008
    Report Date
    November 17, 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
    OH, 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 ON 11/17/2008, 11/18/2008, AND 12/01/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING TWO PTS WITH UNEXPECTED POSTOPERATIVE REFRACTIONS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS IN THIS PATIENT, WAS OFF AXIS. THE PT HAS A YAG LASER PROCEDURE THAT YIELDED VERY LITTLE IMPROVEMENT IN THE PATIENT'S VISUAL ACUITY. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE FIRST PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T3 10747333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention