BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16748259 · Received April 14, 2023

    Report

    Report Number
    3012236936-2023-00878
    Event Type
    Injury
    Date Received
    April 14, 2023
    Report Date
    April 14, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TELEPHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL WITH TECNIS SIMPLICITY, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITY MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. CLINICAL CODE (B)(4) IS PROVIDED FOR INCISION ENLARGEMENT. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE, REASON UNKNOWN; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S CAPSULE RUPTURED FROM THE LEAD HAPTIC OF THE INTRAOCULAR LENS (IOL) DURING IMPLANTATION. THE IOL WAS REMOVED FROM THE PATIENT'S EYE. THE INCISION WAS ENLARGED FOR EXTRACTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818253 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention