BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3950607 · Received July 11, 2014

    Report

    Report Number
    1119421-2014-00535
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 5, 2008
    Report Date
    June 16, 2014
    Manufacturer
    ALCON RESEARCH, LTD. HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THAT THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES APPROXIMATELY SEVEN YEARS AGO, SHE IS EXPERIENCING A 'WAX PAPER FILM' ACROSS HER SIGHT LINE. THIS 'WAX PAPER FILM' APPEARS AT THE SLIGHTEST EYE MOVEMENT. A YAG LASER WAS PERFORMED APPROXIMATELY 15 MONTHS AGO WITH NO VISUAL IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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
    406987 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. HUNTINGTON SA60D3 10715824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other