BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18507959 · Received January 12, 2024

    Report

    Report Number
    3012236936-2024-00095
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    November 15, 2023
    Report Date
    May 9, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474765252
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 02/05/2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT LENS REVEAL THAT IT WAS CUT IN HALF WITH BOTH HAPTICS DETACHED, CONSISTENT WITH A LENS THAT WAS CUT AND EXPLANTED. ONE LENS HAPTIC WAS MISSING. THE LENS WAS FURTHER INSPECTED, AND NO ISSUES WERE OBSERVED THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE. 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN INITIAL REPORT, EVENT DATE WAS MENTIONED AS 12/15/2023. HOWEVER, THE CORRECT EVENT DATE IS 11/15/2023. ALSO, PRODUCT EVALUATION RESULTS PROVIDED IN THE 1ST FOLLOW UP REPORT SUBMITTED IN SECTION H10 TEXT WAS INDICATED INCORRECTLY. IT SHOULD HAVE BEEN NOTED AS "THE LENS WAS FURTHER INSPECTED AND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE WAS OBSERVED. THE COMPLAINT ISSUE "EXPLANT" AND "UNEXPECTED POSTOP REFRACTION" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION". FIELD BELOW IS UPDATED ACCORDINGLY: SECTION B3: DATE OF EVENT: 11/15/2023. ADDITIONAL INFORMATION: AND UPON FURTHER REVIEW INFORMATION RECEIVED FROM ADDITIONAL INFORMATION THAT THE VISUAL ACUITY RESULTS WERE UPDATED. THE PRE-OP BEST CORRECTED VISUAL ACUITY IS 20/20. THE POST-OP (POST-INITIAL IMPLANT) BEST CORRECTED VISUAL ACUITY IS 20/20, THE POST-OP (POST-REPLACEMENT IMPLANT) BEST CORRECTED VISUAL ACUITY, IS 20/20. ALSO, IN FIRST FOLLOW UP REPORT, SECTION H2: FOLLOW UP TYPE WAS MISSED TO MENTION AS "ADDITIONAL INFORMATION" AND "DEVICE EVALUATION". SECTION H3: DEVICE EVALUATED BY MANUFACTURER WAS MISSED TO MENTION AS '"YES". FIELDS BELOW UPDATED ACCORDINGLY: SECTION H2: CORRECTION, ADDITIONAL INFORMATION, DEVICE EVALUATION: BOXES CHECKED. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: BOX CHECKED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAIN IMPLANTED IN THE EYE. 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. ATTEMPTS HAVE 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 THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO POWER SURPRISE, MARKED DEVIATION FROM MEASURED TARGET OBSERVED FIRST DURING POST-OP EXAM. THE LENS WAS EXPLANTED AND REPLACED WITH DXR00VU140 IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO PATIENT INJURY, DAILY ACTIVITIES OF THE PATIENT WERE NOT AFFECTED. THERE WAS INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. THE INTENDED/TARGETED POST-OPERATIVE REFRACTION (FOR INITIAL IMPLANT) WAS :-0.50. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834692 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DXW300 05050474765252

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention