BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21085968 · Received January 6, 2025

    Report

    Report Number
    3012236936-2025-000004
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    August 15, 2024
    Report Date
    March 26, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731776
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION H3: THE DEVICE WAS NOT 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS 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: RETURNED TO MANUFACTURER ON: 2/03/2025. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION REVEAL HALF A LENS PIECE WAS RECEIVED. THE LENS WAS CLEANED AND PRESENTED WITH NO FURTHER ISSUES. CONCLUSION: NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. THE ¿LENS CUT¿ OBSERVED DURING PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. 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 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT DUE TO BLURRY VISION, SHADOWS GHOST IMAGES, GLARES AND STARBURSTS. THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE PATIENT COULD NOT DRIVE AT NIGHT DUE TO VISUAL DISTURBANCES. THE BEST CORRECTED VISUAL ACUITY(BSCVA) PRE-OP WAS 20/50. THE BEST CORRECTED VISUAL ACUITY(BSCVA) POST-OP WAS 20/20. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351600 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731776

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| O