BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20104279 · Received August 29, 2024

    Report

    Report Number
    3012236936-2024-000234
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Report Date
    August 29, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 AND A4: 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: 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 - 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: +81 03-5343-5611 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. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED, AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINTS FOR THIS PRODUCTION ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. AN ATTEMPT HAS 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 HAPTIC OF THE PRELOADED EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS (IOL) WAS DAMAGED DURING IMPLANTATION. THE IOL WAS REMOVED AND THE SURGERY WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT IOL. THERE WERE NO PATIENT INJURIES, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911094 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose