BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 978733 · Received January 11, 2008

    Report

    Report Number
    1119421-2008-00011
    Event Type
    Injury
    Date Received
    January 11, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 13, 2007
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 12/17/2007 BY FAX AND MAIL. A QUESTIONNAIRE WAS RETURNED 01/02/2008.

    Description of Event or Problem · 1

    AN OR TECHNICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE CAPSULE BROKE. IN A FOLLOW-UP, THE SURGEON REPORTS THE LENS WAS REMOVED THROUGH AN ENLARGED INCISION AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE PATIENT'S PROGNOSIS IS REPORTED AS "EXCELLENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 920172

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention VISCOELASTIC