BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17452372 · Received August 3, 2023

    Report

    Report Number
    3012236936-2023-01778
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Report Date
    October 19, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636637
    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

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: SEPTEMBER 19, 2023. 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 RETRACTED. THE HANDPIECE ASSEMBLY WAS INSPECTED AND PRESENTED WITH NO ISSUES. THE COMPLAINT CARTRIDGE, PRESENTED WITH A CARTRIDGE TIP AND CARTRIDGE CRACK. VISCOELASTIC WAS OBSERVED NOT TO BE FULLY DISPERSED THROUGH THE CARTRIDGE INDICATING THAT AN INADEQUATE AMOUNT MAY HAVE BEEN USED. NO LENS WAS RECEIVED WITH THE PRODUCT RETURN. THE COMPLAINT ISSUE OF CARTRIDGE TIP CRACKED/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 OTHER ISSUE OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3 - DATE OF EVENT: DATE UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION D6A - IMPLANT DATE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED SECTION E1 - FIRST/GIVEN NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION E1 - LAST NAME: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION E1 - TELEPHONE NUMBER: (B)(6) SECTION H3 - OTHER (81): THE PRODUCT 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. ATTEMPTS HAVE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF A CARTRIDGE HAD BEEN FOUND TO HAVE A CRACK DURING IMPLANTATION. THE REPORTING PHYSICIAN HAD NO SPECIFIC RESISTANCE FEELING IN THE CARTRIDGE AND THE PLUNGER HAD NO PROBLEM IN MOTION. THE INTRAOCULAR LENS HAD NO DAMAGE OR BREAKAGE, AND THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PRODUCT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325173 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636637

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown