BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 5437514 · Received February 15, 2016

    Report

    Report Number
    2648035-2016-00243
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    January 18, 2016
    Report Date
    April 2, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION WAS PERFORMED AND ONLY A HALF OF LENS WAS RECEIVED. ONE LENS HAPTIC WAS OBSERVED DISTORTED. THE CONDITION OBSERVED IN THE LENS AND THE WAY IN WHICH THE CUT IS FORMED IS CONSISTENT WITH A LENS THAT HAS BEEN CUT DUE TO "IOL REMOVAL" DURING SAME SURGICAL PROCEDURE. THE COMPLAINT ISSUE AS IOL TORN (IOL OPTIC APPEARS CUT, RIPPED/TORN) WAS VERIFIED IN THE RETURNED UNIT. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. NO ISSUES WERE REPORTED DURING THE MANUFACTURING PROCESS OF THIS PRODUCTION ORDER. A SEARCH ON COMPLAINTS REVEALED NO OTHER COMPLAINTS WERE RECEIVED FOR THIS ORDER NUMBER TO DATE. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE MANUFACTURING RECORDS REVIEW, ANALYSIS OF THE RETURN, HISTORICAL COMPLAINT REVIEW AND LABELING REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACK WAS NOTED IN THE INTRAOCULAR LENS (IOL) AND IT WAS REMOVED FROM THE EYE DURING THE SAME SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93794 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1