BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1235689 · Received November 14, 2008

    Report

    Report Number
    1119421-2008-00906
    Event Type
    Other
    Date Received
    November 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. PROD HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. SN60T4 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR