BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1222532 · Received November 6, 2008

    Report

    Report Number
    1119421-2008-00877
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    March 1, 2006
    Report Date
    October 7, 2008
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROCHA RDE C, OECHSLER RA, GARCIA DE CARVALHO R, MOREIRA H. (2007). INFLUENCE OF CORNEAL ASTIGMATISM IN FINAL VISUAL ACUITY AFTER IMPLANTATION OF ACRYSOF RESTOR: CASE REPORT. ARQ BRAS OFTALMOL. 2007 NOV-DEC;70(6):1040-2. THIS REPORT WAS MAILED TO FDA ON:11/06/2008.

    Description of Event or Problem · 1

    IN A LITERATURE REPORT, A SURGEON REPORTS HAVING A PATIENT WITH NEAR AND DISTANCE VISUAL ACUITY WORSE THAN EXPECTED WITH NO IMPROVEMENT IN REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. AFTER 45 DAYS, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. THE FINAL CORRECTED VISUAL ACUITY IMPROVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention