BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20140337 · Received September 4, 2024

    Report

    Report Number
    3012236936-2024-000239
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    May 30, 2024
    Report Date
    October 28, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731783
    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 A4, A5, A6: UNKNOWN/ NOT PROVIDED. ASKU. SECTION H3- NO: 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: OCT. 11, 2024. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE LENS WAS CUT INTO THREE PIECES: TWO PIECES WITH HAPTICS ATTACHED AND ONE MIDDLE PIECE. THE LENS PIECES WERE CLEANED AND INSPECTED, AND NO FURTHER ISSUES WERE OBSERVED. THE COMPLAINT ISSUES REPORTED WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE 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. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION THAT 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 A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO SUBJECTIVE VISUAL DISTURBANCE (VISUAL DISTURBANCE - DARK SHADOWS IN PERIPHERY, "FLUTTERING"). SINGLE SUTURE 10.0 NYLON WAS USED, AS PLANNED. A NON JOHNSON AND JOHNSON IOL WAS USED TO REPLACE THE EXPLANTED LENS. PATIENT SEES RESOLUTION OF TEMPORAL NEGATIVE DYSPHOTOPSIA WITH CLARION MONOFOCAL LENS. THERE WAS NO PATIENT POST-EXPLANT INJURY. PATIENT DOING FINE POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105587 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention