BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17608073 · Received August 23, 2023

    Report

    Report Number
    3012236936-2023-01990
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    July 31, 2023
    Report Date
    November 2, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636569
    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: 11-AUG-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 COMPLAINT HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. FURTHER INSPECTION OF THE CARTRIDGE REVEALED THAT THERE WAS NO VISCOELASTIC RESIDUE DISPERSED THROUGHOUT THE LENGTH OF THE CARTRIDGE, SUGGESTING THAT AN INADEQUATE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) MAY HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. THE HANDPIECE WAS DISASSEMBLED AND THE ASSEMBLY WAS INSPECTED, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. VISUAL INSPECTION OF THE LENS REVEALED IT WAS RECEIVED TAPED TO THE HANDPIECE INSERT. THE LENS WAS REMOVED AND CLEANED, REVEALING THAT THE LENS WAS DAMAGED ON THE SPARE TIRE. THE COMPLAINT ISSUE OF LENS DAMAGED 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. THE COMPLAINT ISSUE OF DEVICE ADVANCEMENT ISSUE WAS NOT CONFIRMED. DURING THE INSPECTION OF THE HANDPIECE/ ASSEMBLY, THERE WERE NO ISSUES IDENTIFIED THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE. 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 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 - IMPLANT DATE: DOES NOT APPLY - LENS WAS NOT IMPLANTED. SECTION D6B - EXPLANT DATE: DOES NOT APPLY - LENS WAS NOT IMPLANTED AND THEREFORE NOT EXPLANTED. 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 LENS DID NOT COME OUT AND WAS CLOGGED WHEN THE PLUNGER WAS TURNED. THEY REMOVED THE LENS FROM THE SIMPLICITY INJECTOR AND FOUND A CRACK AT THE EDGE OF THE OPTIC. ANOTHER LENS WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51657 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636569

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown