BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1442754 · Received August 5, 2009

    Report

    Report Number
    1119421-2009-00741
    Event Type
    Other
    Date Received
    August 5, 2009
    Date of Event
    January 1, 2009
    Report Date
    July 6, 2009
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL#, LOT#, OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED 07/07/2009, 07/08/2009, 07/10/2009 AND 07/21/2009 BY EMAIL, MAIL, FAX AND TELEPHONE. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 08/05/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WITH POOR NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ON POSTOPERATIVE DAY ONE, THE PUPIL WAS EXTREMELY CONSTRICTED (1MM) AND AT ONE WEEK POSTOPERATIVE, THE PUPIL WAS STILL SMALL (2MM). THE PT IS NOT UNHAPPY WITH THE RESULTS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other