BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 16640641 · Received March 29, 2023

    Report

    Report Number
    3012236936-2023-00766
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 9, 2023
    Report Date
    May 16, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558229
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: WE LEARNED THROUGH FOLLOW UP, THAT THE LENS CONTACT WITH THE PATIENT WAS VERY BRIEF. IT WAS VERY APPARENT THAT THE LENS WAS FAULTY FROM THE START. THERE WAS SOME RESISTANCE LOADING. AND THE PLUNGER GOT STUCK AND THE LENS WAS UNABLE TO EJECT FULLY AND WAS VERY QUICKLY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED WITHOUT INCIDENT. NO FURTHER INFORMATION WAS PROVIDED. SECTION H6 -HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT SECTION H6 -HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE: 2339 - INACCURATE DELIVERY ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FAULTY. THROUGH FOLLOW UP WE LEARNED THAT THE IOL CAME OUT WITH AN UNUSUAL SHAPE AND DID NOT OPEN CORRECTLY. THE IOL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE BACK-UP LENS. NO COMPLICATIONS WERE REPORTED AND THERE WERE NO SIGNIFICANT DELAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176684 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown