BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18188760 · Received November 21, 2023

    Report

    Report Number
    3012236936-2023-02808
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 21, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER:(B)(6). SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: HEALTH EFFECT - IMPACT CODE: 4644 (TO CAPTURE MEDICAL INTERVENTION INTERVENTIONAL PROCEDURE AND TOPICAL STEROIDS TREATMENT WITH INTERVENTIONAL PROCEDURE). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT CATARACT SURGERY ON THE RIGHT EYE, WAS EXAMINED ON POST-OPERATIVE DAY 1, AND THE BEST CORRECTED VISUAL ACUITY WAS 1,0 WHICH WAS GOOD. 5 DAYS POST-OP, THE PATIENT COMPLAINED OF REDUCED VISION, DURING A MEDICAL CONSULTATION. THE PATIENT DIDN'T HAVE PAIN. THE VISUAL ACUITY EXAM REVEALED LIGHT PERCEPTION. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS SUSPECTED AND THE PATIENT WAS PRESCRIBED A STEROID SUBCONJUNCTIVAL INJECTION AND OCULAR ADMINISTRATION OF STEROIDS. THE PHYSICIAN WILL WAIT TO OBSERVE THE OUTCOME. ALTHOUGH SLIT PHOTOGRAPH SHOWED THE SYMPTOM SEEMED TO SUBSIDE MORE THAN THE DAY BEFORE, BUT IT HAD NOT RECOVERED YET COMPLETELY. THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. IT WAS NOTED THAT THE PATIENT WAS NOT HOSPITALIZED. A CULTURE EXAMINATION/ PCR (POLYMERASE CHAIN REACTION) WAS NOT PERFORMED. THE POSSIBLE CAUSE WAS NOT DETERMINED BY THE PHYSICIAN. NO TEARS ON THE PRODUCTS PACKAGE. NO ISSUES WITH THE HAND SANITATION OF THE MEDICAL STAFF. FOUR PATIENTS UNDERWENT SURGERY WITH THE DEVICE, ON THE DAY OF THE SURGERY. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669778 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739451

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Other