BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15767543 · Received November 10, 2022

    Report

    Report Number
    3012236936-2022-02815
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 13, 2022
    Report Date
    November 15, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474528925
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION (THE LENS WAS DISCARDED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS REVIEW WAS PERFORMED, AND NO NONCONFORMITY REPORT WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THERE WAS PATIENT CONTACT, BUT THE INCISION WAS NOT ENLARGED. THERE WAS NO INJURY TO THE PATIENT. THE HAPTIC PROBLEM WAS NOTICED QUICKLY AND HANDLED IMMEDIATELY. ADDITIONAL WAS NOTED THAT THE PATIENT WAS (B)(6) YEAR OLD. NO FURTHER INFORMATION WAS PROVIDED THE FOLLOWING FIELD WAS UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION A2: AGE: (B)(6) YRS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON FULL INSERTION OF AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S LEFT EYE, THE TRAILING HAPTIC WAS NOTICED TO BE BROKEN. THE IOL WAS REMOVED AND REPLACED. THE LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE ACCOUNT. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458310 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474528925

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female EMERALD CARTRIDGE, LOT CK07179