BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16665457 · Received April 3, 2023

    Report

    Report Number
    3012236936-2023-00760
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 28, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731615
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, IT WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS IS TO CORRECT THE INITIAL SUBMISSION. SECTION A3, GENDER: IT STATES FEMALE BUT SHOULD HAVE STATED MALE. AND SECTION B5 SAID "A NON JOHNSON AND JOHNSON LENS WAS USED TO COMPLETE THE PROCEDURE". ALSO THE STATEMENT "THE HARM WAS NOT THE RESULT OF THE CONTACT WITH THE PRODUCT. " BUT CORRECT STATEMENT IS JUST "REPLACEMENT LENS INFORMATION WAS NOT PROVIDED." THE FIELD BELOW IS UPDATED: SECTION A3, GENDER: MALE. SECTION B5, DESCRIBE EVENT OR PROBLEM: REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION: UPON FURTHER REVIEW NEW INFORMATION RECEIVED THAT THE PATIENT OUTCOME IS "DOING WELL". ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE AND THEN REMOVED. REPORTEDLY, THE PATIENT¿S CAPSULE TORE. THE HARM WAS NOT THE RESULT OF THE CONTACT WITH THE PRODUCT. THE DOCTOR PERFORMED AN ANTERIOR VITRECTOMY. A NON JOHNSON AND JOHNSON LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO OTHER INJURIES REPORTED AND NO INCISION ENLARGEMENT WAS REQUIRED. THE SUSPECT PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266514 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731615

    Patients

    Seq Age Sex Outcome Treatment
    1 Male