BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17695222 · Received September 6, 2023

    Report

    Report Number
    3012236936-2023-02149
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 9, 2023
    Report Date
    May 14, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636149
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 14-FEB-2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT DEVICE PRESENTED WITH STRESS MARKS AT THE TIP OF THE CARTRIDGE THAT ARE IN THE SPECIFICATION FOR A USED DEVICE. VISCOELASTIC RESIDUE WAS OBSERVED TO NOT BE DISTRIBUTED EVENLY THROUGH THE LENGTH OF THE CARTRIDGE INDICATING THAT AN INADEQUATE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD)/BALANCED SALT SOLUTION (BSS) COULD HAVE BEEN USED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE LENS MODULE WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. THE HANDPIECE WAS DISASSEMBLED AND NO ISSUES WERE IDENTIFIED. THE PLUNGER ROD WAS ADVANCED AND RESISTANCE WAS FELT. THE LENS WAS CLEANED AND PRESENTED WITH SCRATCHES ON THE OPTIC BODY. THE COMPLAINT ISSUE OF COSMETIC ISSUES WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS BASED ON THE PRODUCT EVALUATION. THE COMPLAINT ISSUE ROD STIFF COULD NOT BE CONFIRMED. HOWEVER, THE OBSERVED ISSUE PLUNGER ROD ISSUE IS SIMILAR TO THE COMPLAINT ISSUE ROD STIFF AND PLUNGER ROD ISSUE IS CONFIRMED TO BE RELATED TO THE COMPLAINT ISSUE. CONCLUSION: AS PER COMPLAINT INVESTIGATION RESULTS, A PRODUCT DEFICIENCY OR MALFUNCTION CANNOT BE EXCLUDED AND WILL BE FURTHER INVESTIGATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED SHOULD NEW INFORMATION BE RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 PRELOADED INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED BECAUSE IT WAS DEFECTIVE. THROUGH FOLLOW-UP WE LEARNED THAT THE HANDPIECE WAS DIFFICULT TO ROTATE WHEN ATTEMPTING TO MOVE THE IOL WITH THE INSERTER. THE PHYSICIAN REMOVED THE IOL FROM THE CARTRIDGE TO INSPECT IT BEFORE IMPLANTATION AND THE IOL WAS SCRATCHED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ACCOUNT INDICATED THAT MATERIAL IS AVAILABLE FOR RETURN. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166774 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown