BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17992739 · Received October 23, 2023

    Report

    Report Number
    3012236936-2023-02503
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 28, 2023
    Report Date
    January 8, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636590
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT "G4" FIELD FOR THE PMA NUMBER WAS INADVERTENTLY POPULATED WITH P980040 ON THE INITIAL MDR; THE FIELD SHOULD HAVE BEEN LEFT BLANK. THEREFORE, THE INFORMATION IS BEING CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AS PER THE FOLLOWING: SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 27-OCTOBER - 2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE TIP OF THE CARTRIDGE WAS DAMAGED. FURTHER INSPECTION REVEALED THAT THERE WAS VISCOELASTIC RESIDUE DISPERSED THROUGHOUT THE LENGTH OF THE CARTRIDGE. THE LENS MODULE WAS INSPECTED, AND NO MARKS THAT WOULD INDICATE THAT THE PLUNGER ROD ADVANCED INCORRECTLY COULD BE IDENTIFIED. THE HANDPIECE WAS DISASSEMBLED, AND THE ASSEMBLY WAS INSPECTED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. VISCOELASTIC RESIDUE COULD BE OBSERVED UNDER THE LENS MODULE SUGGESTING THAT AN EXCESSIVE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE OVD AND/OR BALANCED SALT SOLUTION (BSS) MAY HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. A DETACHED HAPTIC WAS RECEIVED (THE REMAINDER OF THE LENS WAS MISSING). NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED BASED ON THE RETURN CONDITION OF THE LENS. THE COMPLAINT ISSUE OF HAPTIC DETACHED WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. SECTION D10, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ALCON BSS PLUS SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; 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 HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, THE INFORMATION WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN HAD NOTICED AFTER SURGERY THAT THE HAPTIC HAD BEEN DETACHED. IT WAS HIGHLY LIKELY THAT IT HAD BEEN BROKEN BEFORE SETTING. THE PHYSICIAN WAS WORRYING WHETHER THE INTRAOCULAR LENS (IOL) HAD BEEN FIXED IN THE EYE. THERE WERE NO SURGICAL INTERVENTIONS PERFORMED OR PLANNED AND NO PATIENT INJURY REPORTED. THE IOL REMAINS IMPLANTED. THROUGH FOLLOW-UP, WE LEARNED, THAT THE TRAILING HAPTIC REMAINED IN THE INJECTOR/CARTRIDGE AFTER THE HAPTIC WAS DETACHED. THE BALANCED SALT SOLUTION (BSS) WAS PROPERLY USED. NO RESISTANCE WAS FELT BY THE PHYSICIAN WHILE HANDLING THE UNIT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847413 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown