BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 20318772 · Received September 27, 2024

    Report

    Report Number
    3012236936-2024-000264
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Report Date
    October 21, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502123
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTED THAT THE SUSPECT PRODUCT EXPIRED ON AUG 15, 2022 AND THE COMPLAINT WAS RECEIVED, SEP 3, 2024. ADDITIONAL VERBIAGE FOR DEVICE EVALUATION AND THE CODE OF H6: 1670 WAS IN ADVERTENTLY NOT INCLUDED ON THE INITIAL MDR MANUFACTURER REPORT NUMBER 3012236936-2024-0002642, THEREFORE, IS BEING CAPTURED IN THIS SUPPLEMENTAL REPORT. THE SERIAL NUMBER SHIPPING HISTORY FOR THIS SERIAL NUMBER WAS REVIEWED AND THE PRODUCT WAS DELIVERED TO THE COMPLAINT CUSTOMER ON MAY 18, 2018, PRIOR TO THE AUGUST 15, 2022, EXPIRATION DATE. PER A SUBJECT MATTER EXPERT (SME), OUR IOLS ARE SUBJECTED TO RIGOROUS PRECLINICAL AND CLINICAL TESTING ACCORDING TO INTERNATIONAL STANDARDS, HOWEVER, THEY HAVE NOT BEEN TESTED PAST THE LABELED EXPIRATION DATE. THEREFORE, THE SAFETY AND EFFECTIVENESS OF AN EXPIRED LENS IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED; IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED; IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). 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 REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH OF COMPLAINTS REVEALED ONE SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER AND THE ISSUE COULD NOT BE CONFIRMED AS RELATED TO MANUFACTURING. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS WARPED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492035 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown