BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 14164617 · Received April 20, 2022

    Report

    Report Number
    3012236936-2022-00904
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 20, 2022
    Report Date
    July 18, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636149
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT, ETHNICITY (RACE): UNKNOWN/ NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. THE DEVICE IS NOT RECEIVED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT INFORMATION "UNKNOWN IF VISUAL DISTURBANCE IS HAPPENING" WAS MISSED IN THE INITIAL REPORT SUBMITTED. THEREFORE, THIS IS CORRECTED IN THIS REPORT. ADDITIONAL INFORMATION: NEW INFORMATION RECEIVED THAT EYE AFFECTED WAS RIGHT EYE, PATIENT DATE OF BIRTH (B)(6)1937, WEIGHT 136 LBS., NO UNPLANNED VITRECTOMY, NO MEDS OUTSIDE OF STANDARD CARE. FIELDS BELOW UPDATED: SECTION A2: PATIENT DATE OF BIRTH: (B)(6)1937. SECTION A4: WEIGHT: 136 LBS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CUSTOMER HAD A PROBLEM WITH A PRE-LOADED LENS. AFTER IT WAS IMPLANTED IN THE EYE, THE ATTENDING NOTICED OPACITY TO THE EDGE OF THE LENS. IT WAS LEFT IN THE EYE BECAUSE THE SURGEONS FELT LIKE THE RISK OF TAKING IT OUT WOULD BE GREATER THAN LEAVING IT IN BECAUSE IT WAS NOT IN THE PATIENT'S FIELD OF VISION. IT WAS STATED THAT THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. THE SURGEON WILL FOLLOW UP WITH THE PATIENT IN CLINIC. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326523 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636149

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female