BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12958234 · Received December 7, 2021

    Report

    Report Number
    2020664-2021-08146
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    October 27, 2021
    Report Date
    February 9, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636064
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: JAN 4 2022. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE COMPLAINT LENS STUCK IN THE CARTRIDGE OF THE SIMPLICITY HANDPIECE. NO DEFECTS OR ASSEMBLY ISSUES WERE OBSERVED WITH THE HANDPIECE PRIOR TO AND AFTER DISASSEMBLY. THE LENS WAS REMOVED AND WAS OBSERVED WITH LENS DAMAGE AND HAPTIC STUCK TO THE OPTIC BODY. TRACE AMOUNTS OF VISCOELASTIC RESIDUE WAS OBSERVED IN THE CARTRIDGE, WHICH SUGGESTS AN INADEQUATE AMOUNT OF OVD WAS USED DURING INSERTION WHICH CAN CONTRIBUTE TO DEPLOYMENT ISSUES (INCLUDING ALL THE DEFECTS LISTED IN THIS EVALUATION). THE COMPLAINT ISSUE COULD NOT BE CONFIRMED BASED ON THE LIMITED INFORMATION PROVIDED BY THE INITIAL REPORT AND THEREFORE NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RETURNED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    AGE, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED HENCE IT WAS NOT EXPLANTED. ATTEMPTS HAVE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SUSPECT PRELOADED PRODUCT WAS RETURNED. IT WAS NOTED THAT VITRECTOMY OCCURRED. BUT UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854773 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention