BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18148839 · Received November 16, 2023

    Report

    Report Number
    3012236936-2023-02868
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    June 6, 2023
    Report Date
    January 13, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731745
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, PATIENT WEIGHT: INFORMATION UNKNOWN/ASKED UNAVAILABLE. SECTION H3-OTHER (81): THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. 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. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, THE CUSTOMER DID NOT PROVIDE IT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: DEC 13, 2023 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED. THE LENS WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS RECEIVED IN A SPECIMEN CUP AND WAS CUT INTO TWO PIECES. THE PIECES WERE STUCK TOGETHER AND WERE SEPARATED THEN CLEANED. NO ISSUES THAT WOULD HAVE CONTRIBUTED OR CAUSED THE COMPLAINT EVENT WERE IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THE PATIENT COMPLAINED OF HALOS, STREAKS, ARCHES OF LIGHT IN THEIR PERIPHERY; DOCTOR DIAGNOSIS IS POSITIVE DYSPHOTOPSIA. THE IOL WAS EXPLANTED. DOCTOR USED LIMBAL RELAXING INCISIONS (LRI). THERE WAS NO SUTURE(S), NO VITRECTOMY, AND NO INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE LENS. THE IOL WAS REPLACED WITH A NON-JNJ LENS MODEL LI61AO +19.0 DIOPTER. THE PATIENT OUTCOME IS REPORTED AS ¿EXCELLENT¿. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108795 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731745

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention