BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 6645125 · Received June 15, 2017

    Report

    Report Number
    2648035-2017-01061
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 22, 2017
    Report Date
    August 2, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474529038
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO EXAMINE THE LENS THOROUGHLY TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT, AND EXAMINE THE LENS OPTICAL SURFACES FOR OTHER DEFECTS. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL MDR, AN INCORRECT PMA/510(K) CODE WAS ENTERED. THE CORRECT CODE IS P990080. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT'S EYE AND A WHITE FILM/DEBRIS WAS NOTICED ON THE EDGE OF THE OPTIC. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO RECORD THE LENS. A SEPARATE MDR WILL BE SUBMITTED FOR THE CARTRIDGE AS ADDITIONAL SUSPECT SOURCE OF THE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425556 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003 05050474529038

    Patients

    Seq Age Sex Outcome Treatment
    1