BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 12305714 · Received August 11, 2021

    Report

    Report Number
    2648035-2021-08269
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    June 11, 2021
    Report Date
    September 8, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558120
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT ONE ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER, HOWEVER, NO PRODUCT DEFICIENCY WAS IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE LENS WAS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD DIFFICULTY IN ADVANCING THE PRELOADED INTRAOCULAR LENS (IOL) AND THE LENS WAS ADVANCED TOO FAR AND EJECTED. THE LENS WAS NOT INSERTED INTO PATIENT'S OPERATIVE EYE. THERE WAS NO INJURY AND NO INTERVENTION WAS PERFORMED. THE PATIENT WAS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205820 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558120

    Patients

    Seq Age Sex Outcome Treatment
    1