BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21465516 · Received February 25, 2025

    Report

    Report Number
    3012236936-2025-000052
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 4, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731684
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6, PATIENT INFORMATION: UNKNOWN/NOT PROVIDED. 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. THEREFORE, NOT EXPLANTED. SECTION D10, CONCOMITANT MEDICAL PRODUCTS: OVD IS OPHTHALMIC VISCOSURGICAL DEVICE AND BSS IS BALANCED SALT SOLUTION (BSS). SECTION H3, DEVICE EVALUATED BY MANUFACTURER: 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. SECTION H6- HEALTH EFFECT - IMPACT CODE: 4625 IS BEING USED TO CAPTURE THE INCISION ENLARGEMENT. AN ATTEMPT WAS MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. 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: FEB 24, 2025. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS RECEIVED ATTACHED TO TAPE AND CUT IN HALF. IT WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS REMOVED FROM THE TAPE AND CLEANED. THE LENS PRESENTED WITH NO FURTHER ISSUES. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. 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 PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED WITHIN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-JOHNSON AND JOHNSON IOL. THE INCISION WAS ENLARGED BUT NO VITRECTOMY WAS REQUIRED. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS EVENT. THE EVENT IS NOT RELATED TO A MISCALCULATION ISSUE, IMPROPER FIT, OR MANUFACTURER DEFECT. THE CUSTOMER USED OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND BALANCED SALT SOLUTION (BSS). THEY ALLOWED BOTH THE OVD AND BSS TO ACCLIMATIZE TO THE ROOM TEMPERATURE AND THERE WERE NO DELAYS IN THE SURGERY AFTER THE INSERTER WAS PREPPED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618031 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention OVD, BSS.