BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 15952201 · Received December 9, 2022

    Report

    Report Number
    3012236936-2022-03055
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 3, 2022
    Report Date
    December 28, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731721
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SURGERY TECHNICIAN (TECH) WAS GIVEN THE PRELOADED INTRAOCULAR LENS (IOL) TO PREPARE FOR SURGERY AND ADDED BALANCED SALT SOLUTION (BSS), LIKE NORMAL. WHEN THE TECH TRIED TO ADVANCE THE LENS, RESISTANCE WAS EXPERIENCE, BUT THE LENS WAS ABLE TO BE MOVED TO THE TIP OF THE INSERTER. WHEN THE SURGEON TRIED TO ADVANCE THE LENS FURTHER IT WOULD NOT MOVE; IT WAS STUCK. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK-UP LENS (SAME MODEL AND DIOPTER). AFTER THE PROCEDURE WAS COMPLETED, THE TECH ATTEMPTED TO GET THE LENS OUT OF THE INSERTER AND WAS ABLE TO REMOVE IT WITH LOTS OF FORCE. THE LENS WAS VERY HARD AND WRAPPED UP LIKE A TACO OR BURRITO. NO PACKAGING DAMAGE OR ISSUE WAS OBSERVED. SURGEON WAS DR. AN VO. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: SECTION E1: COMPLAINT REPORTER TITLE, FIRST AND LAST NAME: (B)(6). SECTION E2: HEALTHCARE PROFESSIONAL: YES. SECTION E3: OCCUPATION: PHYSICIAN. SECTION H6: MEDICAL DEVICE PROBLEM CODE: 2983 - MECHANICAL JAM AND 1487 - DEVICE DIFFICULT TO SETUP OR PREPARE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    IF IMPLANTED/EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT AND TO OBTAIN SUSPECT PRODUCT FOR EVALUATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS HARD AND FOLDED UPON REMOVAL FROM PACKAGING. WHEN THE LENS WAS OPENED PRIOR TO SURGERY, THE LENS WAS FOLDED OVER LIKE A TACO AND HARD AND ALL DRIED OUT. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597970 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731721

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown