BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7039290 · Received November 16, 2017

    Report

    Report Number
    9614546-2017-01113
    Event Type
    Injury
    Date Received
    November 16, 2017
    Report Date
    November 12, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING 2017. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. THERE IS A PLANNED EXPLANT TO BE PERFORMED SOMETIME IN THE MONTH OF (B)(6) 2017. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED PROVIDED THE INTRAOCULAR LENS (IOL) SERIAL NUMBER AS (B)(4). ADDITIONALLY, THE IMPLANT DATE WAS REPORTED AS (B)(6) 2017 AND EXPLANT DATE OF (B)(6) 2017. A NEW LENS (MODEL AND DIOPTER UNKNOWN) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT WAS PERFORMED. THE EXPLANTED IOL WAS DISCARDED. THE PATIENT'S GENDER AND DATE OF BIRTH WAS ALSO REPORTED. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: DATE OF BIRTH: (B)(6). GENDER/SEX: FEMALE. DEVICE EXPIRATION DATE: 4/10/2022. SERIAL NUMBER: (B)(4). UDI NUMBER: (B)(4). CATALOG NUMBER: ZXR00U0215. IF IMPLANTED, GIVE DATE: (B)(6) 2017. IF EXPLANTED, GIVE DATE: (B)(6)2017. DEVICE MANUFACTURE DATE: 4/10/2017. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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. THE SERIAL NUMBER IS UNKNOWN, THEREFORE THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED SOMETIME IN (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF HALOS AND GLARE, EVEN THOUGH THE PATIENT SEES WELL ON THE SNELLEN CHART. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817530 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other