BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18389193 · Received December 22, 2023

    Report

    Report Number
    3012236936-2023-03275
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 30, 2023
    Report Date
    December 22, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4 (PATIENT WEIGHT), A5 (ETHNICITY): UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS REMAINS IMPLANTED. SECTION H3-OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAINS IMPLANTED; 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT HE HAD AN INTRAOCULAR LENS (IOL) WHERE THE TRAILING HAPTIC WAS STUCK TO THE LENS WHICH HE SAID TO BE NOT UNCOMMON. WHEN THE DOCTOR TRIED TO TUG THE HAPTIC OFF, IT WAS VERY STUCK (TENACIOUS) AND DID NOT POP OFF LIKE USUAL. WHEN THE DOCTOR DID GET IT TO POP OFF, THERE WAS A CHUNK OF SOMETHING LEFT ON THE HAPTIC THAT LOOKED STRINGY, LIKE RUBBER CEMENT AS HE PULLED IT AWAY. THE DOCTOR COULD NOT PULL THE GLOB OFF THE HAPTIC AND IT ENDED UP IN THE PERIPHERY OF THE PATIENT¿S EYE. THE DOCTOR FELT IT WAS TOO RISKY AT THIS POINT TO TRY TO REMOVE THE GLOB. IT WAS INDICATED THAT THERE IS A SMALL MARK ON THE LENS AS WELL WHERE IT WAS ATTACHED. THE DOCTOR WAS VERY DISTURBED ABOUT THIS ISSUE. IT WAS NOTED THAT TINY AMOUNT OF MATERIAL REMAINS AT ANTERIOR LENS SURFACE - PERIPHERY OF OPTIC, NO INFLAMMATION NOTED. (DOCTOR DILATED PATIENT FOR 1-WEEK EXAM). THERE WAS NO PATIENT INJURY OR COMPLICATIONS SUCH AS CAPSULE TEAR REPORTED. THERE WAS NO MEDICATION OUTSIDE THE STANDARD OF CARE PRESCRIBED, NO VITRECTOMY REQUIRED, AND NO SUTURES USED. THE LENS REMAINS IMPLANTED IN PATIENT¿S RIGHT EYE. THE CURRENT PATIENT OUTCOME IS GOOD, AND THE REPORTED ISSUE DID NOT IMPACT THE PATIENT'S VISUAL ACUITY, NO VISUAL ISSUES. THE DOCTOR¿S NEXT PLAN OF ACTION IS OBSERVATION AS LONG AS RECOVERY NORMAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290741 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male