BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1132288 · Received June 13, 2008

    Report

    Report Number
    1119421-2008-00440
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 16, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL; THE DEVICE REMAINS IMPLANTED. PROD HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED 05/27/2008 AND 05/29/2008 BY PHONE, FAX AND MAIL. ADD'L INFO WAS RECEIVED 05/27/2008 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A MEDWATCH WAS RECEIVED FROM THE FDA REPORTING A CONSUMER WITH BLURRY NEAR AND INTERMEDIATE VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE CONSUMER REPORTED HEADACHES WHEN READING FOR EXTENDED PERIODS OF TIME, STATES PRINT SEEMS TO HAVE GHOST IMAGES, AND REPORTS PRESSURE-LIKE PAIN. SHE FEELS HER VISION IS WORSE THAN BEFORE THE IMPLANT SURGERY. IN A F/U WITH THE CONSUMER, SHE REPORTS THAT HER SURGEON STATES EVERYTHING IS NORMAL IN HER EYES. SHE STATES SHE NEEDS MAGNIFYING GLASSES TO READ. SHE HAS A HISTORY OF DRY EYES FOR WHICH SHE IS USING DROPS FOR RELIEF, BUT STATES THEY DO NOT HELP VERY MUCH. SHE STATES THE EYE PAIN AND PRESSURE IS WORSE WHEN SHOPPING, READING, AND IN INFLUORESCENT LIGHTING. SHE IS ABLE TO SEE TELEVISION AND COMPUTER SCREENS WITHOUT ANY PROBLEMS. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other SYSTANE