BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12071116 · Received June 25, 2021

    Report

    Report Number
    2648035-2021-08002
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731806
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING 2021. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED.  DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE PRELOADED INTRAOCULAR LENS (IOL) WAS BEING INSERTED, SURGEON NOTICED THAT THE TRAILING HAPTIC WAS NOT TUCKED INSIDE THE LENS AS IS TYPICAL, BUT INSTEAD, WAS ALIGNED STRAIGHT. HE USED A SECOND INSTRUMENT TO DIAL THE TRAILING HAPTIC INTO THE EYE AND CENTERED THE LENS. THE PLACEMENT OF THE LENS WAS ON POINT AND NO FURTHER PROBLEMS OCCURRED. THERE WAS NO PATIENT INJURY. PATIENT¿S POST-OP DAY 1 VISIT WAS TYPICAL AND NO FURTHER PROBLEMS/COMPLICATIONS WERE OBSERVED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964847 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731806

    Patients

    Seq Age Sex Outcome Treatment
    1