BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1243155 · Received November 21, 2008

    Report

    Report Number
    1119421-2008-00938
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 10/24/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/28/2008.

    Description of Event or Problem · 1

    A NURSE REPORTS THAT FIVE MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL WAS EXCHANGED BECAUSE IT WAS NOT SECURE IN THE BAG IN A PATIENT WITH GLAUCOMA. DURING THE EXCHANGE PROCEDURE, THE SURGEON REPORTS THAT AN ANTERIOR VITRECTOMY AND ENLARGEMENT OF THE INCISION WERE DONE AND SUTURES WERE PLACED. HE ALSO STATES THAT ONE MONTH AFTER THE INITIAL IMPLANT SURGERY, POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED AND A YAG LASER WAS DONE. IN A FOLLOW-UP, IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10766689

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention ACULAR| PRED FORTE| RESTASIS| ZYMAR| REFRESH PM| VISCOELASTIC