BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17746048 · Received September 14, 2023

    Report

    Report Number
    3012236936-2023-02321
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 22, 2023
    Report Date
    March 15, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739451
    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 A2, A4 AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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.

    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: 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. ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 19-SEP-2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT NO LENS WAS RECEIVED. THE HANDPIECE WAS DISASSEMBLED, AND THE ASSEMBLY WAS DISASSEMBLED, AND THE ASSEMBLY WAS INSPECTED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. THE COMPLAINT CARTRIDGE WAS RECEIVED COATED IN VISCOELASTIC RESIDUE ALONG THE LENGTH OF THE CARTRIDGE, SUGGESTING THAT AN ADEQUATE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS USED. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. FURTHER EVALUATION OF HE COMPLAINT PRODUCT REVEALED THAT THE CARTRIDGE WAS DYED AND IT LOOKED LIKE A NORMAL CARTRIDGE. THERE WAS SOME INDICATION THAT THE PUSHROD MOVED OUT OF THE CENTER RAIL (INDICATED TO MOVE TO THE LEFT SIDE OF THE INJECTOR) AS THE LENS WAS PUSHED INTO THE CARTRIDGE BUT OTHER THAN THAT, NOTHING UNUSUAL WAS NOTED. NO REASON COULD BE OBSERVED FOR THE CENTRAL TRIANGULAR DAMAGE TO THE LENS DUE TO THE INJECTOR. THE COMPLAINT ISSUE OF COSMETIC ISSUES WAS IDENTIFIED DURING THE EVALUATION OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. 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 AFTER IMPLANTATION OF THE LENS, A SCRATCH WAS DISCOVERED ON THE LENS PERIPHERY, EVEN THOUGH THE PHYSICIAN DIDN'T ENCOUNTER ANY RESISTANCE DURING PLACEMENT. THE SCRATCH WAS NOT LOCATED ON THE CENTER OF THE OPTIC AND THERE WERE NO PROBLEMS WITH STABILITY IN THE EYE. THEREFORE, THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252003 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739451

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown