BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 7054684 · Received November 22, 2017

    Report

    Report Number
    9614546-2017-01155
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474552203
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN REVIEW OF INITIAL MDR HAD AN INCORRECT PRODUCT CODE OF POE AND SHOULD BE HQL. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: PROCODE: HQL DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED TO THE MANUFACTURING SITE AS IT WAS DISCARDED. 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. 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

    DATE OF EVENT: UNKNOWN, AN EXACT DATE WAS NOT PROVIDED. THE BEST ESTIMATE IS BETWEEN (B)(6) 2017. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (MODEL ZCT150, +23.0 DIOPTER) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) YEAR-OLD FEMALE PATIENT. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE, BECAUSE THE PATIENT WAS NOT HAPPY WITH THE VISION. NO INCISION ENLARGEMENT AND NO VITRECTOMY WAS PERFORMED. REPORTEDLY, THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY. ANOTHER TORIC LENS, SAME MODEL SMALLER DIOPTER (+22.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED BEING HAPPY WITH HER VISION AFTER THE EXCHANGE. THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831962 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT150 05050474552203

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention