BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21402603 · Received February 18, 2025

    Report

    Report Number
    3012236936-2025-000028
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    December 19, 2024
    Report Date
    June 30, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474761780
    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

    ADDITIONAL INFORMATION. SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: APR 4, 2025 SECTION H3: EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED. VISUAL INSPECTION WAS PERFORMED REVEALING THE LENS WAS COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED WHICH REVEALED A CHIP ON THE EDGE OF THE LENS. THE CHIPPED PIECE WAS MISSING. DAMAGE WAS OBSERVED ON THE SURFACE OF THE LENS. NO FURTHER ISSUES WERE OBSERVED. 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.

    Additional Manufacturer Narrative · 0

    SECTION A3B, GENDER: UNKNOWN/NOT PROVIDED. 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. ATTEMPTS HAVE BEEN 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT EXPERIENCING SPIDER WEBS AND EXCESSIVE GLARE. THE IOL WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS (MODEL DRN00V, 19.5 DIOPTER). THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523705 TECNIS SIMPLICITY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. DXR00V 05050474761780

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention