BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1905532 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01291
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 27, 2010
    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
    CA, 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 10/27/2010, 10/28/2010, AND 11/01/2010 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVED ON 11/01/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING "FOG" AND A GRADUAL LOSS OF VISUAL ACUITY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE WAS GIVEN TREATMENTS FOR DRY EYE AND INFLAMMATION. HE ALSO REPORTED THAT A YAG LASER WAS DONE NINE MONTHS AFTER THE IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED FOR A POSTOPERATIVE VISIT APPROX ONE MONTH AFTER THE YAG PROCEDURE. THE RECORDS INDICATED THAT THE LENS WAS IN PLACE AND ALL EYE STRUCTURES WERE NOTED TO BE NORMAL/CLEAR. BLURRED VISION CONTINUES TO BE EXPERIENCED BY THE PT AND THAT THE YAG PROCEDURE AND TREATMENT FOR DRY EYES HAVE NOT HELPED. IN A F/U, THE SURGICAL COORDINATOR FOR THE SURGEON REPORTED THAT THE SURGEON IS NOT BLAMING THE IOL FOR THE PT'S SYMPTOMS, RATHER THERE MAY BE UNDERLYING UNK ISSUES. THE SURGEON HAS REFERRED THE PT TO A RETINAL SPECIALIST; HOWEVER, THE PT CANCELLED THE VISUAL FIELD TEST AND DID NOT FOLLOW THROUGH WITH INSTRUCTIONS FOR RETINAL CONSULT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10870401

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention