BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 12502962 · Received September 20, 2021

    Report

    Report Number
    2020664-2021-07276
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 20, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474529090
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ORIGINAL LENS CASE, ORIGINAL FOLDING CARTON, PATIENT STICKERS, PATIENT ID CARD, IMPLANT ID CARD, AND DFU WERE RECEIVED. ADDITIONAL DOCUMENTATION WAS ALSO RECEIVED. NO COMPLAINT LENS WAS RECEIVED, AND THEREFORE NO PRODUCT EVALUATION COULD BE PERFORMED ON THE LENS. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED ONE COMPLAINT ISSUE REPORTED BUT IS NOT RELATED; THEREFORE, NO FURTHER ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE '2199 - NO HEALTH CONSEQUENCES OR IMPACT' PROVIDED ON THE INITIAL REPORT NEEDS TO BE CORRECTED. THE CORRECT IMPACT CODE IS 4627 - DEVICE EXPLANTATION AS THE LENS WAS REPORTED REMOVED. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H6: HEALTH EFFECT - IMPACT CODE 2199 NO HEALTH CONSEQUENCES OR IMPACT NO LONGER APPLIES AND IS REPLACED WITH 4627 - DEVICE EXPLANTATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S RIGHT EYE AS IT WAS OBSERVED WITH A BROKEN HAPTIC AFTER IT WAS FULLY INSERTED INTO THE EYE. PATIENT WAS REPORTEDLY DOING GREAT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400516 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474529090

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female