BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRSYOF

    MDR report key: 1040484 · Received May 9, 2008

    Report

    Report Number
    1119421-2008-00300
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 9, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    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 04/11/2008, 04/14/2008 AND 04/23/2008 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WITH AN UNEXPECTED POST-OPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS ( IOL) IMPLANT SURGERY. THE SURGEON HAS PERFORMED LIMBAL RELAXING INCISIONS BUT THE PT IS NOT HAPPY WITH THE RESULTING REFRACTION. IN A FOLLOW-UP, THE SURGEON REPORTS THE PT PROGNOSIS AS "GOOD" AND THAT THE PT IS WEARING STRONG GLASSES. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRSYOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. MN60AC 10735100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention