BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1253138 · Received December 5, 2008

    Report

    Report Number
    1119421-2008-00991
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 6, 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
    NJ, 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 INFORMATION WAS REQUESTED ON 11/07/2008, 11/10/2008, AND 11/24/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS HAVE BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN UNCORRECTED ASTIGMATISM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENT ALSO HAD A SUDDEN ELEVATION OF INTRAOCULAR PRESSURE (IOP) WHICH WAS RELIEVED BY PARACENTESIS; AS WELL AS, MEDICATION. THE SURGEON STATED THAT THE PATIENT HAS EPIRETINAL MEMBRANE AND TOLD THE PATIENT, PRIOR TO SURGERY, THE RETINA MAY LIMIT VISION. POSTOPERATIVELY, THE SURGEON NOTED CORTICAL DEBRIS UNDER THE IOL AND STATED THAT THE LENS IS IN POSITION AND NOT TILTED. ADDITIONAL INFORMATION 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 10821366

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention