BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1912685 · Received December 2, 2010

    Report

    Report Number
    9614546-2010-00063
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS DISCARDED AT THE SURGERY SITE AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE INITIAL IMPLANT WAS REPLACED WITH THE SAME MODEL OF A HIGHER DIOPTER. MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. A REVIEW OF COMPLAINT RECORDS REVEALED THAT NO ADDITIONAL COMPLAINTS FROM THIS LOT WERE RECEIVED. BASED ON OUR INVESTIGATION AND THE FACT THAT NO LENS WAS AVAILABLE, NO FURTHER INVESTIGATION COULD BE PERFORMED. THIS SPECIFIC COMPLAINT ANALYSIS IS INCONCLUSIVE BUT NOT THOUGHT TO BE RELATED TO THE IOL. LENS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED ON (B)(6) 2010 WITHOUT COMPLICATION 1 MONTH AFTER THE INITIAL IMPLANT. THE CAUSE OF THE IOL EXPLANT WAS UNDESIRED REFRACTIVE OUTCOME. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, ONE DIOPTER HIGHER POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention