BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 11685509 · Received April 19, 2021

    Report

    Report Number
    2648035-2021-07628
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 19, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655492
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS IOL REMAINS IMPLANTED. REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING AND HISTORICAL RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AS PART OF PO ( PURCHASE ORDER ) (B)(4) AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) REMAINED STUCK TOGETHER. THE SURGEON MUST HAVE USED 2 INSTRUMENTS TO SEPARATE THEM. THERE WAS NO IMPACT ON THE PATIENT. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584970 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655492

    Patients

    Seq Age Sex Outcome Treatment
    1