BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 6730162 · Received July 20, 2017

    Report

    Report Number
    2648035-2017-01306
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 28, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474530577
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS OBSERVED THAT THE INFORMATION IN PMA/510(K) OF THE INITIAL REPORT WAS INCORRECT. THE PMA/510(K) # IN THE INITIAL REPORT STATES P980040, BUT THE CORRECT PMA/510(K) NUMBER FOR THE DEVICE IN THIS EVENT IS P880081. PMA/510(K) # P880081. ADDITIONAL INFORMATION CONFIRMING THAT THE LENS WAS REMOVED FOR REFRACTIVE PURPOSES BECAUSE PATIENT OUTCOME WAS NOT AS EXPECTED. THERE WAS NO COMPLICATIONS AND NO PRODUCT ISSUES. DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 07/31/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION : THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE LENS WAS RECEIVED CUT IN TWO PIECES. WHAT APPEAR TO BE BLOOD, VISCOELASTIC RESIDUES AND SLIGHTLY SCRATCHES WERE OBSERVED. THE HAPTICS LOOKS POSITIONED. THE CONDITION OF THE LENS IS TYPICALLY OF A REMOVED OR AN EXPLANTED LENS. NO MAJOR DEFECTS WERE OBSERVED IN THE LENS. THE COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A Z9002 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, A LARGER, 16.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT NO SUTURES AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509280 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002 05050474530577

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention