BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 4150142 · Received October 7, 2014

    Report

    Report Number
    2648035-2014-00533
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - OUTCOME INTERFERES WITH THE PATIENT''S DAILY ACTIVITIES.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SAMPLE WAS RECEIVED CUT INTO THREE PIECES AND WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. PARTICLES AND FIBERS WERE OBSERVED ON THE LENS SURFACE. A SCRATCH WAS OBSERVED IN THE OPTIC ZONE CLOSE TO THE PERIPHERY. ONE OF THE HAPTICS WAS OBSERVED DETACHED. THE CONDITION OF THE LENS RECEIVED IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT¿S EYE. THE MANUFACTURING RECORD REVIEW WAS PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT IS EXPERIENCING MUCH GLARE LIKE ''SNAPSHOTS OF LIGHT''. DOCTOR REPORTED HE SAW FRACTURE LINES IN THE OPTIC OF INTRAOCULAR LENS (IOL). IT HAS BEEN THREE MONTHS SINCE IMPLANT. IT WAS REPORTED THAT THE OUTCOME SIGNIFICANTLY INTERFERES WITH PATIENT ACTIVITIES OF DAILY LIFE. THE INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY PROCEDURE ON (B)(6) 2014, DUE TO THE DOCTOR BELIEVING THE LENS WAS FRACTURED IN 3 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627716 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention