BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7322389 · Received March 7, 2018

    Report

    Report Number
    9614546-2018-00229
    Event Type
    Injury
    Date Received
    March 7, 2018
    Report Date
    July 11, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    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 · 0

    ADDITIONAL INFO/CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT DID NOT HAVE THE INTRAOCULAR LENS (IOL) EXCHANGED AS THE TEAR FILM STABILIZED. THIS EVENT HAS NOW BEEN DETERMINED NOT TO BE A REPORTABLE EVENT. NO FURTHER REPORTS WILL BE SUBMITTED UNDER THIS MANUFACTURER REPORT NUMBER 9614546-2018-00229. PATIENT CODE FROM 3191 (PLANNED EXPLANT) TO 2692. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2017 & (B)(6) 2018. LENS REMAINS IMPLANTED. HOWEVER, AN EXPLANT IS PLANNED IN THE NEXT COUPLE OF WEEKS. THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMFONY TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THERE IS A PLANNED EXPLANT SCHEDULED. REPORTEDLY, THE EXPLANT WILL TAKE PLACE IN THE NEXT COUPLE OF WEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163690 TECNIS SYMFONY TORIC TORIC IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention