BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 6649150 · Received June 16, 2017

    Report

    Report Number
    2648035-2017-01079
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 11, 2017
    Report Date
    August 1, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PMA# OF THE INITIAL MDR AN INCORRECT PMA NUMBER WAS ENTERED. THE CORRECT PMA NUMBER FOR THE REPORTED IOL IS P990080. ADDITIONAL INFORMATION WAS RECEIVED AND THE CUSTOMER STATED THAT THE PHYSICIAN THOUGHT THE LENS WOULD CAUSE AN ANGLE CLOSURE, SO THE PHYSICIAN EXPLANTED THE LENS. SERIAL (B)(4). EXPIRATION DATE: 10/18/2015. (B)(4). MANUFACTURING DATE: 10/18/2015. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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 ZA9003 29.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE DESCRIPTION OF THE EVENT WAS THAT THE LENS WAS PLACING THE PATIENT IN AN ANGLE CLOSURE, SO THE LENS HAD TO BE REMOVED. THE PHYSICIAN IS LETTING THE EYE SETTLE DOWN BEFORE IMPLANTING A REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427360 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention