BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 4123589 · Received September 26, 2014

    Report

    Report Number
    2648035-2014-00507
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 09/19/2014. THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE VISUAL INSPECTION NOTED THAT THE LENS WAS OBSERVED CUT IN TWO (2) PARTS. BOTH OF THE HAPTICS/LOOPS WERE OBSERVED DISTORTED. THE LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION. LOOSE PARTICLES WERE OBSERVED ON THE LENS SAMPLE COMPATIBLE WITH HANDLING THE LENS. RESIDUE OF VISCOELASTIC (OVD) WAS DETECTED ON THE LENS. THE SAMPLE WAS OBSERVED WITH THE CHARACTERISTIC OF SILICONE MATERIAL AND LENS HAS A FROSTED EDGE WHICH IS TYPICAL IN SILICONE LENSES, MODEL Z9002. THE LENS WAS CUT DUE TO THE EXPLANT AND BASED ON THE EVIDENCE OBSERVED, THE LENS WAS NOT AFFECTED BY THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THE REVIEW OF THE DOCUMENTATION PRESENTED IN THE MANUFACTURING RECORD WAS FOUND WITHIN PRODUCT SPECIFICATIONS. NO DEVIATION OR NON-CONFORMANCE RELATED TO THE CUSTOMER REPORT WAS GENERATED. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A Z9002 23.5 DIOPTER INTRAOCULAR LENS WAS INSERTED INTO THE PATIENT¿S EYE AND A VITRECTOMY WAS REQUIRED. THE LENS IS NOTED AS IT IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF SUBMISSION OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599962 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention