BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 12471870 · Received September 14, 2021

    Report

    Report Number
    2020664-2021-07378
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 21, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502116
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE(S) 4582 PROVIDED ON THE INITIAL REPORT NEEDS TO BE REMOVED AS IT SHOULD NOT HAVE BEEN INDICATED IN THE INITIAL REPORT. ALSO FOR HEALTH EFFECT IMPACT CODE 4632 SHOULD BE ADDED. FIELD BELOW UPDATED: SECTION H6: HEALTH EFFECT IMPACT CODE: 4632 (CAPTURES DELAY IN TREATMENT). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED LENS WAS REMOVED AND REPLACED ON THE SAME PROCEDURE. INCISION WAS ENLARGED AND SUTURES WERE NECESSARY. THERE WAS A DELAY OF 20 MINS. PATIENT CLAIMED TO BE PERMANENTLY IMPAIRED. THE FOLLOWING FIELDS UPDATED: SECTION H6: HEALTH EFFECT: IMPACT CODE: 4631 (REMOVAL AND REPLACEMENT) SECTION H6: HEALTH EFFECT: IMPACT CODE: 4625 (INCISION ENLARGEMENT AND SUTURES) (DELAY) SECTION H6: HEALTH EFFECT: CLINICAL CODE: 4581 (DELAY / PATIENT CLAIMED PERMANENTLY IMPAIRED). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, NO PATIENT CONTACT WITH PRODUCT. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, NO PATIENT CONTACT WITH PRODUCT. TELEPHONE NUMBER: (B)(6). 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 & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAPTIC DAMAGED ON THEIR SENSAR AR40E INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365795 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown