BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3981085 · Received August 5, 2014

    Report

    Report Number
    2648035-2014-00388
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD/MANUFACTURING RECORD REVIEW WERE PERFORMED, AND THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. LENSES ARE MEASURED FOR INTRAOCULAR LENS (IOL) DIOPTER POWER, RESOLUTION, AND CONTRAST. AT THE FINAL INSPECTION PROCESS, THE LENSES ARE 100% INSPECTED AT 10X MICROSCOPE MAGNIFICATION. THE OPERATORS PERFORM A MEASUREMENT INSPECTION AND DISPOSITION ACCORDING TO SPECIFICATION FOR VISUAL INSPECTION OF ACRYLIC INTRAOCULAR LENSES. BASED ON THE MANUFACTURING RECORD REVIEW, NO DEVIATION OR ASSIGNABLE CAUSE WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SAMPLE WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION, WHICH IS OUR NORMAL INSPECTION MAGNIFICATION. THE VISUAL INSPECTION REVEALED A CUT IN THE LENS FROM THE EDGE TO BEYOND THE CENTER. SOME SCRATCHES AND CUTS WERE ALSO OBSERVED. ONE HAPTIC OF THE LENS WAS OBSERVED DETACHED AND MISSING. ALSO, VISUAL INSPECTION REVEALED SURFACE RESIDUALS (FIBER/PARTICLES) ON THE LENS COMPATIBLE WITH HANDLING THE LENS NON-STERILE ENVIRONMENT. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT HAS BEEN REMOVED FROM THE PATIENT'S EYE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE PATIENT'S LEFT EYE WITHIN THE SAME PROCEDURE. IT WAS STATED THAT THE IOL WAS NOT SECURE IN THE POSITION DUE TO THE PATIENT'S ANATOMY. IT WAS STATED THAT ONCE THE LENS WAS IN PLACE, A LOSS OF ZONULAR SUPPORT AND TEAR IN THE POSTERIOR CAPSULE WERE NOTED WITH NO VITREOUS PRESENT. ATTEMPTS WERE MADE TO SUTURE THE IOL TO THE IRIS, BUT WERE UNSUCCESSFUL. IT WAS STATED THAT AN ANTERIOR LENS WAS PLACED INSTEAD. NO PATIENT INJURY WAS REPORTED. IT WAS STATED THAT THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456389 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention