BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 6720381 · Received July 17, 2017

    Report

    Report Number
    2648035-2017-01284
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    April 19, 2017
    Report Date
    August 10, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474530614
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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

    IN PMA# SECTION OF THE INITIAL MDR AN INCORRECT PMA NUMBER WAS PROVIDED. THE CORRECT PMA NUMBER FOR THE COMPLAINT DEVICE IS P880081. DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 07/18/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. THE DEVICE WAS RETURNED TO THE MANUFACTURER. HOWEVER, PRODUCT TESTING WAS NOT PERFORMED SINCE THE EVENT IS RELATED TO PATIENT ISSUES. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO ADDITIONAL INVESTIGATION REQUEST FOR THIS PO 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 16.0 DIOPTER INTRAOUCLAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO MYOPIC OUTCOME. THERE WAS NO ISSUE WITH THE LENS, THE PHYSICIAN ATTRIBUTES THE EVENT TO PATIENT ISSUES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER SIZE (13.5). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499353 TECNIS CL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS Z9002 05050474530614

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention