BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11137578 · Received January 8, 2021

    Report

    Report Number
    2648035-2021-07038
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 7, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636088
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. DEVICE EVALUATION: SINCE PRODUCT REMAINS IMPLANTED, THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. 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 · 1

    IT WAS REPORTED THAT A DOCTOR HAD ISSUES WITH OUR PRELOADED PRODUCT. THE DOCTOR IMPLANTED A DCBOO AND THE POSTERIOR SIDE OF THE LENS WAS SCRATCHED. THERE WAS NO NEED TO INTERVENE AND THE LENS WAS LEFT INSERTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39688 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636088

    Patients

    Seq Age Sex Outcome Treatment
    1