BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18187845 · Received November 21, 2023

    Report

    Report Number
    3012236936-2023-02822
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    November 1, 2023
    Report Date
    May 2, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636583
    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

    SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED SECTION E1 - TELEPHONE NUMBER: (B)(6) 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. 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 AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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 AS THE NARRATIVE INDICATED THAT THE REPORT WAS BEING FILED ON AN INTERNATIONAL DEVICE THAT HAS A SIMILAR DEVICE DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 08-APR-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 THE PLUNGER ROD FULLY ADVANCED. VISCOELASTIC PRESENTED DISPERSED THROUGHOUT THE LENGTH OF THE CARTRIDGE SUGGESTING AN ADEQUATE AMOUNT WAS USED. THE LENS MODULE WAS INSPECTED AND NO DAMAGE OR VISCOELASTIC RESIDUE WAS IDENTIFIED. THE HANDPIECE ASSEMBLY WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. THE PLUNGER ROD ADVANCEMENT WAS INSPECTED AND RESISTANCE WAS FELT. NO LENS WAS RETURNED FOR EVALUATION. THE COMPLAINT ISSUE OF DIFFICULT TO USE COULD NOT BE CONFIRMED. HOWEVER, THE OBSERVED ISSUE OF PLUNGER ROD ISSUE IS SIMILAR TO THE COMPLAINT ISSUE DIFFICULT TO USE AND PLUNGER ROD ISSUE IS CONFIRMED TO BE RELATED TO THE COMPLAINT ISSUE. THIS WILL BE FURTHER INVESTIGATED AND A SUPPLEMENTAL REPORT WILL BE FILED SHOULD RELEVANT NEW INFORMATION BE PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED A FEELING OF RESISTANCE WHEN TURNING THE ROD/ PLUNGER OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), WHICH GRADUALLY INCREASED AS THE IOL MOVED FORWARD TO THE TIP OF ITS CARTRIDGE. THE IOL HAD SLIGHTLY CRACKED AT THE BASE OF THE TRAILING HAPTIC AND IT WAS UNKNOWN WHETHER THE IOL HAD BEEN IMPLANTED. THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL REMAINS IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863251 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown