BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7077110 · Received December 1, 2017

    Report

    Report Number
    9614546-2017-01187
    Event Type
    Injury
    Date Received
    December 1, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ATTEMPTS HAVE 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) 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: AS THE SERIAL NUMBER IS UNKNOWN FOR THIS EVENT, IT IS NOT POSSIBLE TO PERFORM ANY MANUFACTURING RECORD EVALUATION OR COMPLAINT HISTORY REVIEW. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT COMPLAINED OF DISABLING NIGHT TIME SYMPTOMS DESCRIBED AS A COBB WEBS FROM HEADLIGHTS AT NIGHT WHICH MAKES HER UNABLE TO DRIVE AT NIGHT. DOCTOR MENTIONED THAT PATIENT HAS A SYMFONY INTRAOCULAR LENS (IOL) MODEL ZXR00 IN THE RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT DOCTOR HOPES PATIENT MIGHT NOT NEED AN EXCHANGE IN RIGHT EYE. THE WEB COVERS THE ENTIRE CAR AND MAKES HER UNABLE TO DRIVE SAFELY AT NIGHT. UNFORTUNATELY, DOCTOR DID A YAG IN THE RIGHT EYE AND THERE WAS NO IMPROVEMENT. SHE CAN CORRECT TO 20/20 BUT THE SYMPTOMS PERSIST. HER EYES ARE OTHERWISE NORMAL. PATIENT HAS BILATERAL LENS IMPLANTS AND THE DOCTOR EXCHANGED THE LEFT EYE. DOCTOR HOPES THAT HE WILL NOT HAVE TO EXCHANGE THE RIGHT EYE BUT SUSPECTS HE MIGHT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855538 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other