BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16782592 · Received April 21, 2023

    Report

    Report Number
    3012236936-2023-00989
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Report Date
    May 18, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SURGEON HAS DOZENS OF CASES WHERE THE TRAILING HAPTIC WAS STUCK TO THE OPTIC AND A SECOND INSTRUMENT WAS REQUIRED TO UNSTICK IT. IN EACH OF THE CASES, THE SURGEON USED A STRAIGHT CONNOR WAND AND A SECOND BENT CONNOR WAND AND USED BOTH TO SQUEEZE THE BULB OF THE HAPTIC AND LIFT IT OFF THE OPTIC AND THEN IT WOULD RELEASE. THE SURGEON REPORTED THAT IT TAKES ABOUT 10 SECONDS. THE SURGEON HAS ATTEMPTED TO "TAP" THE LENS FIRST, TO SEE IF IT CAN BE "KNOCKED A CERTAIN WAY", AND IN "1 OUT OF 15 CASES" IT CAN BE "TAPPED" AND IT WORKS, HOWEVER IN THE OTHER CASES, THE SURGEON NOTED THAT IT IS MORE THAN JUST A "TAP" ¿ IT IS MECHANICALLY LIFTING THE HAPTIC OFF THE OPTIC. NO FURTHER INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION 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 ON MORE THAN ONE OCCASION, THE MAJORITY OF THE TIME, THE INTRAOCULAR LENS (IOL) TRAILING HAPTIC STICKS TO THE OPTIC AND A SECOND INSTRUMENT IS REQUIRED TO UNSTICK IT. THE SURGEON NOTED THAT "IT IS NOT A BIG DEAL" FOR THE SURGEON, BUT IT DOES ADD A FEW SECONDS TO THE CASE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792516 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown