BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1620488 · Received March 1, 2010

    Report

    Report Number
    1119421-2010-00189
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    December 1, 2009
    Report Date
    January 29, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 INFORMATION WAS REQUESTED ON 01/29/2010, 02/01/2010, 02/02/2010, 02/03/2010, 02/17/2010, AND 02/21/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/22/2010. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE SURGEON DOES NOT BELIEVE THERE WAS A PROBLEM WITH THE IOL, BUT WAS UNWILLING TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 10944640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other