BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1290894 · Received December 5, 2008

    Report

    Report Number
    1119421-2008-00988
    Event Type
    Other
    Date Received
    December 5, 2008
    Date of Event
    December 1, 2006
    Report Date
    November 11, 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
    IL, 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 11/07/2008, 11/11/2008, 11/21/2008, AND 11/25/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/01/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED HAVING TIRED, IRRITATED EYES, AS WELL AS, BLURRY VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE WAS REFERRED TO A CORNEA SPECIALIST AND WAS TOLD SHE HAS DRY EYES. SHE WAS GIVEN MEDICATION FOR THE DRY EYES WHICH DID NOT HELP AND SHE DISCONTINUED. SHE IS USING GLASSES FOR READING. SHE STATED THAT THE DOCTORS HAVE TOLD HER THE LENSES ARE PERFECTLY PLACED AND NOT THE CAUSE OF HER COMPLAINTS. IN A FOLLOW-UP, IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE 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 SN60D3 923973

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other