BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SYMFONY OPTIBLUE

    MDR report key: 6840805 · Received September 3, 2017

    Report

    Report Number
    9614546-2017-00835
    Event Type
    Malfunction
    Date Received
    September 3, 2017
    Date of Event
    August 8, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474610200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE LENS WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT COULD NOT BE VERIFIED. PHOTO OF THE IMPLANTED LENS AND THE SURGERY ANIMATION WERE RECEIVED. REVIEW OF THE PHOTO SHOW SCRATCHES ON THE IMPLANTED PRODUCT. REVIEW OF THE SURGERY ANIMATION SHOW IMPROPER PRODUCT HANDLING. THE DAMAGE SEEN IS MOST PROBABLY RELATED TO HANDLING OF THE DEVICE. CONSIDERING THE IMPLANT PROCEDURE IT DOES SUGGEST THE DAMAGE WAS INTRODUCED DURING MANUFACTURING. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORDS WERE REVIEWED AND THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER TO DATE. 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. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THERE IS NO INDICATION THAT THE LENS WAS EXPLANTED. (B)(6). 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE (1) MONTH POSTOP EXAMINATION BY MYDRIASIS, THE DOCTOR OBSERVED SOME KIND OF SCRATCH MARKS ON THE OPTIC OF AN INTRAOCULAR LENS (IOL), MODEL ZXR00V. THE VISUAL ACUITY IS 1.2D (20/16). REPORTEDLY, THE SURGEON IS TAKING A WAIT-AND-SEE APPROACH. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620643 TECNIS SYMFONY OPTIBLUE MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00V 05050474610200

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR