BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SENSAR

    MDR report key: 11255533 · Received January 29, 2021

    Report

    Report Number
    2648035-2021-00010
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Report Date
    June 29, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA:   THIS REPORT IS TO CORRECT THE INITIAL VMSR.   SECTION B5 INITIALLY REPORTED <NOE> 3 </NOE> EVENTS. CORRECTING THE NUMBER OF EVENTS FROM <NOE> 3 </NOE>  TO <NOE> 1 </NOE> EVENTS. THE REMAINING 2 EVENTS WILL BE SUBMITTED AS INDIVIDUAL INITIAL MDRS.   BASED ON THE REPORTED INFORMATION, 1 EVENT MEETS THE CRITERIA FOR A SINGLE MALFUNCTION CODE (1069). THE REMAINING 2 EVENTS CONTAIN OTHER ANCILLARY DETAILS IN ADDITION TO THE MALFUNCTION CODE (1069). THEREFORE, THESE 2 EVENTS WILL BE SUBMITTED AS INITIAL INDIVIDUAL MDRS. REFER TO THE LIST BELOW FOR THE 2 AFFECTED SERIAL NUMBERS: (B)(6) ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THERE IS 1 INVESTIGATION COMPLETED DURING THIS PERIOD. BREAKDOWN OF 1 COMPLETED INVESTIGATION: (B)(6), NO PRODUCT RETURNED. THE INVESTIGATIONS CONCLUDED, THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA. AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. THAT WAS RECEIVED, DURING THE TIME PERIOD THAT COVERS THIS VOLUNTARY MALFUNCTION SUMMARY REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT RELATED TO LENS DAMAGED. A REVIEW OF EVENT INDICATED THAT THE IOL MODEL AAB00 EXPERIENCED LENS DAMAGED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BREAKDOWN OF 3 EVENTS IS AS FOLLOWS: COSMETIC ISSUES: 1. LENS DAMAGED : 1. LENS DAMAGED, INSERTER PROBLEM: 1. UNIQUE IDENTIFIER (UDI#): ONLY A PORTION OF THE UDI IS PROVIDED. SERIAL NUMBER OF THE SUSPECT PRODUCT: (B)(4): 1.(B)(4): 1.(B)(4): 1. 2 INVESTIGATION WERE COMPLETED, AND 1 INVESTIGATION IS PENDING FROM THIS PERIOD. BREAKDOWN OF 2 COMPLETED INVESTIGATIONS: (B)(4): NO PRODUCT RETURNED. (B)(4): NO PRODUCT RETURNED. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. A REVIEW OF THE RECORDS RELATED TO THE DEVICE INCLUDING COMPLAINT TREND AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED THEN 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

    THIS REPORT SUMMARIZES (NOE) 3 (/NOE) MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151778 SENSAR MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. AAB00

    Patients

    Seq Age Sex Outcome Treatment
    1