BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 7043511 · Received November 17, 2017

    Report

    Report Number
    9614546-2017-01124
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    February 5, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474610156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 11/06/2017. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THE PRODUCT IS DAMAGED AND INCOMPLETE, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. THE PRODUCT WAS ALSO INSPECTED BY A QUALIFIED INSPECTOR USING A 12X MAGNIFICATION, IT CAN BE SEEN THAT A PART OF THE HAPTIC IS MISSING AND THE OPTIC BODY IS BEING CUT IN. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE IS (B)(6) 2017. INITIAL REPORTER PHONE NUMBER: (B)(6). PMA 510(K): THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER ZXR00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. ZXR00, WHICH FALLS UNDER PMA P980040. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXR00V 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED 1 MONTH AFTER THE INITIAL IMPLANTATION BECAUSE THE PATIENT'S MYOPIA WAS NOT FIXED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820864 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00V 05050474610156

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention