BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3760102 · Received April 18, 2014

    Report

    Report Number
    9614546-2014-00087
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE LENS WAS RECEIVED CUT IN TWO PIECES WHEREBY THE OPTIC WAS DAMAGED AND SCRATCHES WERE PRESENT. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE PATIENT'S EYE. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION REVEALED THE LENS TO BE TECNIS MULTIFOCAL ACRYLIC 1-PIECE INTRAOCULAR LENS. THE INITIAL REPORT STATED THE DOCTOR MISSED THE REFRACTIVE GOAL AND INDICATED THAT IT WAS NOT A PRODUCT COMPLAINT. THE MANUFACTURING RECORD REVIEW INDICATED THAT THERE WERE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS WITH RESPECT TO THE PRODUCTION ORDER NUMBER. THERE WERE NO PROCESS AND / OR MATERIAL CHANGES WITHIN THE PRODUCTION ORDER NUMBER. THE STERILIZATION BATCH WAS RELEASED WITH NO NON-CONFORMANCES. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): EXPLANT OF INTRAOCULAR LENS. REFRACTIVE ERROR.ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REQUIRED TO BE EXPLANTED FROM THE RIGHT EYE OF A PATIENT IN A SECONDARY PROCEDURE AS THE SURGEON MISSED THE REFRACTIVE GOAL. A NEW ZMB00 LENS WITH 19.5 DIOPTER POWER (SERIAL NUMBER: (B)(4)) WAS IMPLANTED IN THE EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236946 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention