BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16892911 · Received May 9, 2023

    Report

    Report Number
    3012236936-2023-01184
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 19, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731844
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A5: ETHNICITY: WHEN ASKED, THE RACE/ETHNICITY WAS INDICATED TO BE CAUCASION/WHITE. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT WHICH THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B5: BOTH BALANCED SALT SOLUTION (BSS) AND ANKAVISC WERE USED FOR LUBRICATION. NO ADDITIVES USED IN THE BSS AND IT WAS AT ROOM TEMPERATURE. ANAKAVISC & BSS WAS INTRODUCED INTO THE CARTRIDGE FROM TIP AS WELL AS THE CANOPY. SECTION D10: CONCOMITANT MEDICAL PRODUCTS: BALANCED SALT SOLUTION (BSS) AND ANKAVISC. SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: MAY 22, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: HE COMPLAINT LENS WAS RECEIVED IN A SPECIMEN CUP. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED CUT IN PIECES WITH A DETACHED HAPTIC. NO FURTHER DEFECTS WERE OBSERVED. THE COMPLAINT ISSUE OF ¿LENS DAMAGED¿ WAS NOT CONFIRMED. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CENTRAL OPTIC DEFECT ON DELIVERY OF AN INTRAOCULAR LENS (IOL). THE ISSUE WAS NOTICED WHEN INSERTING THE LENS INTO THE PATIENT¿S RIGHT EYE. THE LENS WAS INSERTED AND REMOVED ON THE SAME DAY. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT. NO MEDICAL OR UNPLANNED SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS REPORTED TO BE DOING FINE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599843 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731844

    Patients

    Seq Age Sex Outcome Treatment
    1 Female BSS AND ANKAVISC