BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW 3

    MDR report key: 18731586 · Received February 19, 2024

    Report

    Report Number
    9613160-2024-00005
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 19, 2024
    Manufacturer
    LENSTEC BARBADOS INC.
    Product Code
    MFK
    PMA / PMN Number
    P200020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REVIEW OF THE BATCH DOCUMENTATION, LENSTEC CAN CONFIRM THAT ALL PROCEDURES IN THE MANUFACTURING AND PACKAGING OF THE DEVICE WERE CONDUCTED CORRECTLY. ADDITIONALLY, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS FROM THIS BATCH. THERE WAS NO EVIDENCE TO SUGGEST THAT ANY ASPECT OF THIS DEVICE WAS RESPONSIBLE FOR THE REPORTED BLURRY VISION. FURTHERMORE, LENSTEC CONFIRMS THAT THE LENS, ITS DESIGN AND THE MANUFACTURING PROCESS ARE NOT AT FAULT DUE TO THE EXTENSIVE TESTING THAT WE HAVE PERFORMED ON THIS MODEL.

    Additional Manufacturer Narrative · 0

    BASED ON THE REVIEW OF THE BATCH DOCUMENTATION, LENSTEC CAN CONFIRM THAT ALL PROCEDURES IN THE MANUFACTURING AND PACKAGING OF THE DEVICE WERE CONDUCTED CORRECTLY. ADDITIONALLY, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS FROM THIS BATCH. THERE WAS NO EVIDENCE TO SUGGEST THAT ANY ASPECT OF THIS DEVICE WAS RESPONSIBLE FOR THE REPORTED BLURRY VISION. FURTHERMORE, LENSTEC CONFIRMS THAT THE LENS, ITS DESIGN AND THE MANUFACTURING PROCESS ARE NOT AT FAULT DUE TO THE EXTENSIVE TESTING THAT WE HAVE PERFORMED ON THIS MODEL.

    Description of Event or Problem · 0

    LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "I RECENTLY HAD CLEARVUE LENSES IMPLANTED IN BOTH EYES. A MECHANIAL FAILURE HAS BEEN IDENTIFIED, AS MY VISION HAS NOT IMPROVED."

    Description of Event or Problem · 0

    LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "I RECENTLY HAD CLEARVUE LENSES IMPLANTED IN BOTH EYES. A MECHANIAL FAILURE HAS BEEN IDENTIFIED, AS MY VISION HAS NOT IMPROVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386850 CLEARVIEW 3 INTRAOCULAR LENS MFK LENSTEC BARBADOS INC. SBL-3 SB12100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown