BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16925025 · Received May 12, 2023

    Report

    Report Number
    3012236936-2023-01033
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 18, 2023
    Report Date
    September 28, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731592
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION. THIS IS TO CORRECT THE INITIAL SUBMISSION SECTION H6 HEALTH EFFECT ¿ IMPACT CODE. IT INCORRECTLY REPORTED 2199 =NO HEALTH CONSEQUENCES OR IMPACT. THE CODE SHOULD NOT HAVE BEEN INCLUDED. ADDITIONAL INFORMATION. SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: JUN 15, 2023. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED AND EVALUATED. A "SCUFF" MARK WAS OBSERVED ON THE POSTERIOR OF THE IOL. THE INSPECTION OF ALL ASSEMBLY RELATED ITEMS REVEALED NO ANOMALIES. NO ASSEMBLY ISSUES 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.

    Additional Manufacturer Narrative · 0

    SECTION A, PATIENT INFORMATION: A4, A5: INFORMATION UNKNOWN/ASKU. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. 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 THE MISSING INFORMATION; HOWEVER, INFORMATION WAS NOT AVAILABLE. 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) HAD A SCRATCH. THE IOL WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE. UPON INSERTION THE LENS WAS NOTICED TO HAVE A ¿SPOT¿ WHICH CUSTOMER CLARIFIED TO BE A SCRATCH ON THE LENS. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO A SCRATCH, DIVET OR DEFECT IN THE CENTER OF THE IOL. THE REPLACEMENT LENS IS THE SAME MODEL AND DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. THE OUTCOME DOES NOT INTERFERE WITH ACTIVITIES OF DAILY LIFE. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED OR IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310302 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731592

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female