BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943636 · Received December 14, 2010

    Report

    Report Number
    1119421-2010-01390
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 16, 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
    AZ, 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. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THREE YRS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER VISION BECAME BLURRY. SHE STATED THAT SHE EXPERIENCED A SLIGHT RETINAL BLEED WHICH CLEARED WITHIN TWO WEEKS. THE CONSUMER REPORTED SHE CANNOT READ WITH OR W/O OVER THE COUNTER READING GLASSES. AT THE REQUEST OF THE CONSUMER, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10736871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other