BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 15731542 · Received November 4, 2022

    Report

    Report Number
    3012236936-2022-02756
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 4, 2022
    Report Date
    January 27, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739345
    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: IN REVIEW, IT WAS NOTED THAT THE SECTION "G4" OF THE INITIAL MDR REPORT WAS INADVERTENTLY POPULATED WITH THE PMA# P980040 WHICH IS INCORRECT. THE "G4" FIELD SHOULD HAVE BEEN KEPT EMPTY AND THE JUSTIFICATION FOR THAT SHOULD HAVE BEEN CAPTURED TO THE SECTION "H10" OF THE INITIAL MDR REPORT. IN REVIEW, IT WAS ALSO NOTICED THAT THE ORDER WHICH THE PRODUCT INVESTIGATION CONCLUSION WAS ENTERED IN THE INITIAL MDR REPORT WAS INCORRECT AND HAD BEEN DISLOCATED. THE INFORMATION HAS BEEN CORRECTED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE OPTIBLUE SIMPLICITY, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY TECNIS EYHANCE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. CONCLUSION: THE COMPLAINT ISSUE 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: NOV 15, 2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: NO COMPLAINT LENS WAS RETURNED FOR EVALUATION. THE ORIGINAL COMPLAINT FOLDING CARTON, HANDPIECE, IMPLANT NOTIFICATION CARD, AND DIRECTION FOR USE (DFU) WERE RECEIVED AS WELL. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED PLUNGER ROD TIP DAMAGE. NO DEFECTS OR ASSEMBLY ISSUES WERE OBSERVED WITH THE HANDPIECE BEFORE AND AFTER DISASSEMBLY. A CUSTOMER PROVIDED MOVIE WAS REVIEWED IN WHICH A DETACHED HAPTIC AND LENS DAMAGE WAS OBSERVED. THE POTENTIAL ROOT CAUSE OF THE COMPLAINT ISSUE COULD NOT BE DETERMINED FROM THE PROVIDED MOVIE. THE COMPLAINT ISSUE 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    AGE AND WEIGHT: UNKNOWN/ASKED BUT UNAVAILABLE. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE ACCOUNT DID NOT HAVE THE INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE, THE HAPTIC CAME OUT TORN. THE LENS WAS REMOVED AND THE BACK UP LENS WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521668 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown