BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1943546 · Received December 3, 2010

    Report

    Report Number
    1119421-2010-01341
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 5, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED ON 11/12/2010, 11/18/2010, AND 11/22/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A MYOPIC OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE IOL WAS WELL POSITIONED AND WITHOUT DEFECTS. HE SUSPECTS THE REFRACTIVE ERROR WAS DUE TO CALCULATION ERROR, BUT DOES NOT HAVE ANY PREOPERATIVE DATA TO CONFIRM THIS BECAUSE HE WAS NOT THE IMPLANTING SURGEON. ADD'L 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 69 YR Other