BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1941814 · Received December 8, 2010

    Report

    Report Number
    1119421-2010-01352
    Event Type
    Other
    Date Received
    December 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 8, 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
    OH, 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 INFO WAS REQUESTED 11/09/2010, 11/12/2010 AND 11/23/2010 BY PHONE, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED 11/10/2010 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/07/2010. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE IS UNABLE TO READ WITHOUT GLASSES FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE IOL DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THE EVENT CONTINUES AND THAT IT IS A "SUBJECTIVE REPORT" FROM THE PT. THE SURGEON ALSO REPORTED THAT THE PT HAS PRE-EXISTING DRY EYE AND CURRENTLY ON DRY EYE THERAPY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10951532

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other MONARCH DELIVERY SYSTEM| DISCOVISC| DRY EYE THERAPY