BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19944760 · Received August 8, 2024

    Report

    Report Number
    3012236936-2024-000212
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 24, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739529
    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. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION H3: 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE 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

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: A VIDEO PROVIDED BY THE CUSTOMER WAS RECEIVED AND EVALUATED. THE VIDEO DISPLAYED THE IMPLANTATION OF A LENS AND A BLACK FIBER CAN BE OBSERVED AT THE SURGICAL WOUND. A SURGICAL SWAB AND PETRI DISH WERE RECEIVED AND INSPECTED UNDER MAGNIFICATION. NO FOREIGN MATERIAL COULD BE IDENTIFIED. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING VIDEO 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: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT JUST BEFORE THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL) WAS IMPLANTED, A BLACK FIBROUS FOREIGN MATTER WAS FOUND WHEN THE IOL PASSED THROUGH THE CARTRIDGE. THE FOREIGN MATTER WAS REMOVED WITH FORCEPS BECAUSE IT WAS CAUGHT IN THE INCISION. BALANCED SALT SOLUTION WAS USED DURING SETTING AND IT WAS INTRODUCED AT THE END OF IRRIGATION AND ASPIRATION. THE OPHTHALMIC VISCOSURGICAL DEVICE USED WAS FROM ANOTHER MANUFACTURER. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE IOL REMAINS IMPLANTED. THERE WAS NO PROBLEM WITH THE PATIENT'S VISUAL ACUITY. THE VISUAL ACUITY WAS ABOUT 0.8, DUE TO THE PRE-EXISTING CONDITION OF DIABETES MELLITUS. THE PATIENT ALSO HAS A MEDICAL HISTORY OF COLORECTAL CANCER AND OCULAR SURFACE DISEASE (OPE). NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636158 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male