BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7162659 · Received January 3, 2018

    Report

    Report Number
    9614546-2018-00015
    Event Type
    Injury
    Date Received
    January 3, 2018
    Report Date
    July 27, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474605183
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 1/22/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS CUT IN HALF, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND REPLACED WITH A NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4158 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXT150 05050474605183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention