BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1251953 · Received December 4, 2008

    Report

    Report Number
    1119421-2008-00985
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    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 11/05/2008, 11/06/2008, 11/13/2008 AND 11/20/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/26/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THREE YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE IS EXPERIENCING IMPAIRED VISION AND FOREIGN BODY SENSATION, AND SEES HALOS WHILE DRIVING. THE SURGEON REPORTED THAT THE PATIENT WAS BEING TREATED FOR DRY EYES WITH PUNCTAL PLUGS AND MEDICATION. POSTERIOR CAPSULE OPACIFICATION (PCO) WAS NOTED IN 2007. A YAG LASER PROCEDURE WAS PERFORMED IN 2008. LIMBAL RELAXING INCISION (LRI) PROCEDURE WAS PERFORMED AT ABOUT ONE MONTH LATER. IN A FOLLOW-UP, THE SURGEON REPORTED THE OUTCOME OF THE EVENT AS "GOOD" WITH AN EXCELLENT PROGNOSIS SINCE DRY EYE TREATMENT WAS REINSTITUTED. THE SURGEON DOES NOT FEEL THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SA60D3 920470

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention