BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 6681147 · Received June 30, 2017

    Report

    Report Number
    2648035-2017-01186
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    March 6, 2017
    Report Date
    August 20, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474530621
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN SECTION OF THE INITIAL MDR AN INCORRECT PMA/510(K) NUMBER WAS PROVIDED. THE CORRECT PMA NUMBER FOR THE REPORTED DEVICE IS P880081. DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 7/21/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE LENS WAS RECEIVED CUT AT THE CENTER WITH VISCOELASTIC RESIDUES; THIS CONDITION IS TYPICALLY OF AN EXPLANTED LENS. THE REPORTED COMPLAINT CANNOT BE VERIFIED DUE TO THE CONDITION OF THE LENS RECEIVED. THE CUSTOMER'S REPORTED EVENT COULD NOT BE CONFIRMED IN THE RETURNED SAMPLE. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINT HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE DEVICE. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A Z9002 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO A RESIDUAL REFRACTIVE OUTCOME. THE LENS WAS EXPLANTED WITH NO COMPLICATION, NO INJURY AND NO ADDITIONAL PROCEDURES PERFORMED. THE LENS WAS REPLACED WITH A DIFFERENT MODEL WITH THE SAME DIOPTER SIZE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462591 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002 05050474530621

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention