BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7085509 · Received December 5, 2017

    Report

    Report Number
    9614546-2017-01198
    Event Type
    Injury
    Date Received
    December 5, 2017
    Report Date
    April 27, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURING SITE. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. 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 JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE STATUS OF THE LENS WAS NOT PROVIDED. THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR SAID THAT SYMFONY INTRAOCULAR LENSES (IOLS) HAVE MORE PROBLEMS IN REGARDS TO SPIDER WEBBING THAN TORIC MULTIFOCAL IOLS EVER DID AND THAT HE COULD FIGURE OUT WHY. REPORTEDLY, THIS HAS HAPPENED ON TWO OR THREE PATIENTS AND HE MAY HAVE TO EXPLANT THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED. AS DOCTOR REPORTING MULTIPLE EVENTS, 2 MDRS WILL BE FILED. THIS REPORT REPRESENTS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861926 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other