BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17344343 · Received July 18, 2023

    Report

    Report Number
    3012236936-2023-01846
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 21, 2023
    Report Date
    April 12, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636712
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    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: 12-JUL-2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT HANDPIECE WAS RECEIVED WITH A DETACHED HAPTIC IN THE CARTRIDGE WHICH WAS OVERRIDDEN BY THE PLUNGER ROD. VISCOELASTIC RESIDUE WAS IDENTIFIED TO NOT BE DISTRIBUTED THROUGHOUT THE ENTIRE LENGTH OF THE CARTRIDGE SUGGESTING AN INADEQUATE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICES /BALANCED SALT SOLUTION WAS USED WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. THE HANDPIECE ASSEMBLY WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. THE DETACHED HAPTIC WAS REMOVED AND THE LENS WAS CLEANED. THE REMAINING HAPTIC ON THE LENS WAS DIMENSIONALLY INSPECTED AND NO ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUE OF HAPTIC DETACHED 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. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. 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.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A - IMPLANT DATE: IMPLANT DATE DOES NOT APPLY BECAUSE THE LENS WAS REMOVED DURING THE SAME PROCEDURE. SECTION D6B - EXPLANT DATE: EXPLANT DATE DOES NOT APPLY BECAUSE THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND HAS NEVER BEEN IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) 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. 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 REPORTING PHYSICIAN HAD FOUND THE LEAD HAPTIC WAS MISSING FROM THE LENS. THE ISSUE WAS FOUND DURING THE INSERTION OF THE IOL (INTRAOCULAR LENS) FROM THE INJECTOR INTO THE PATIENT¿S EYE. THE PHYSICIAN HAD TO REMOVE THE LENS BY ENLARGING THE INCISION. THE REPORTER HAD NOT HAD ANY FEELING OF RESISTANCE OR SCRATCHING WHEN TURNING ITS PLUNGER, AND THE IOL HAD ENTERED THE EYE SMOOTHLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER LENS WITH A DELAY OF 30 MINUTES. THERE WAS NO PATIENT INJURY OR HEALTH DAMAGE. THROUGH FOLLOW UP WE LEARNED THAT THE SURGEON HAD TO SUTURE THE INCISION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862300 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention