BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19068865 · Received April 9, 2024

    Report

    Report Number
    3012236936-2024-00958
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    December 27, 2023
    Report Date
    June 7, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731783
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVES/DATA: BASED ON ADDITIONAL INFORMATION REVIEW. THE FOLLOWING SECTION HAVE BEEN ADDED TO REFLECT THE NEW INFORMATION: SECTION D1:TECNIS SIMPLICITY. SECTION D2A:INTRAOCULAR LENS. SECTION D2B: HQL. SECTION D4: MODEL NUMBER: DIB00. SECTION D4:CATLOG NO : DIB00U0215. SECTION D4: SERIAL NUMBER:(B)(6). SECTION D4: EXPIRATION DATE: JUN 11, 2026 SECTION D4: UNIQUE IDENTIFIER (UDI) NUMBER:(B)(4). SECTION D6A: IF IMPLANTED, GIVE DATE: (B)(6) 2023. SECTION H4: DEVICE MANUFACTURE DATE: JUN 11, 2023 CORRECTION : BASED ON ADDITIONAL INFORMATION REVIEW AS ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS A REPLACEMENT (SAME MODEL, DIFFERENT DIOPTER OF 21.0), THERE IS A GREATER THAN 1 DIOPTER DIFFERENCE BETWEEN THE IMPLANTED LENS AND THE EXCHANGE LENS, WITH NO INJURY. BASED ON THE ADDITIONAL INFORMATION REVIEW, THE CODES FROM THE INITIAL MDR OF CODE 1845 - UNSPECIFIED INJURY IS NO LONGER APPLICABLE. THE REPORTABILITY (SECTION B1 AND B2) ARE NO LONGER APPLICABLE AND CASE IS CONSIDERED AS NOT REPORTABLE. THE FOLLOWING CODES HAVE BEEN ADDED TO REFLECT THE NEW INFORMATION: SECTION H6: CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS THERE WILL NO LONGER BE ANY FURTHER REPORTING UNDER MFR REPORT NUMBER 3012236936-2024-00958. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVES/DATA: BASED ON ADDITIONAL INFORMATION RECEIVED, PATIENT IS DOING WELL AND NO COMPLAINTS. THE FOLLOWING SECTION HAVE BEEN ADDED TO REFLECT THE NEW INFORMATION: SECTION A2 : AGE AT TIME OF THE EVENT: 58 YEARS. SECTION A3 :GENDER: FEMALE . SECTION A4 :PATIENT WEIGHT : 148 LBS. SECTION A6:RACE : WHITE. SECTION D4: MODEL NUMBER: DIB00 21.5. SECTION D4:CATLOG NO : UNK DIB. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN/ INFORMATION NOT PROVIDED. SECTION D4- MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4- SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4- UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A:UNKNOWN, INFORMATION NOT PROVIDED. SECTION H3: OTHER 81: THE DEVICE 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. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN INTRAOCULAR LENS HAD EXCHANGE DUE TO AN UNKNOWN REASON. IT WAS UNKNOWN IF THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. THE PRODUCT IS BEING RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513519 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731783

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention