BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 13793998 · Received March 17, 2022

    Report

    Report Number
    3012236936-2022-00683
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Report Date
    March 30, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. CONCLUSION: BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE AN INDICATION OF PRODUCT MALFUNCTION OR PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN REVIEWING THE INITIAL MDR, IT WAS NOTICED THAT THE FOLLOWING INFORMATION WAS ADDRESSED INAPPROPRIATELY IN H10; THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT: SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAS AN OPACITY AND SCRATCH ON PERIPHERAL OF LENS, IN THE 5 O'CLOCK POSITION. THE SURGEON THINKS SOMETHING IS SCRATCHING OR SQUASHING THE LENS AS IT PASSES THROUGH THE INSERTER. THE SURGEON DESCRIBES HOW BALANCED SALT SOLUTION (BSS) IS ADDED IMMEDIATELY BEFORE ADVANCING THE LENS AND RIGHT BEFORE THE LENS IS HANDED OFF TO THE SURGEON. THE SURGEON QUESTIONED THE TIME FRAME THE BSS SHOULD SIT BEFORE ADVANCING THE LENS. THE LENS REMAINS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823331 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown