BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TECNIS CL

    MDR report key: 11256435 · Received January 31, 2021

    Report

    Report Number
    2648035-2021-00017
    Event Type
    Malfunction
    Date Received
    January 31, 2021
    Report Date
    June 29, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P880081
    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> 24 </NOE> EVENTS. CORRECTING THE NUMBER OF EVENTS FROM <NOE> 24 </NOE>  TO <NOE> 13 </NOE> EVENTS. THE REMAINING 11 EVENTS WILL BE SUBMITTED AS INDIVIDUAL INITIAL MDRS.   BASED ON THE REPORTED INFORMATION, 13 EVENTS MEET THE CRITERIA FOR A SINGLE MALFUNCTION CODE (1069). HAPTIC DETACHED AND HAPTIC DAMAGED ARE CONSIDERED LENS DAMAGED AND ARE CODED AS(1069). THE IOL IS COMPRISED OF THE OPTIC AND HAPTICS WHICH IS A SINGLE DEVICE. THE REMAINING 11 EVENTS CONTAIN OTHER ANCILLARY DETAILS IN ADDITION TO THE MALFUNCTION CODE (1069). THEREFORE, THESE 11 EVENTS WILL BE SUBMITTED AS INITIAL INDIVIDUAL MDRS. REFER TO LIST BELOW FOR THE 11 AFFECTED SERIAL NUMBERS: (B)(6).ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE ARE 4 INVESTIGATIONS COMPLETED DURING THIS PERIOD. BREAKDOWN OF 4 INVESTIGATIONS WITH RESPECTIVE SERIAL NUMBERS ARE AS FOLLOWS: (B)(6). COSMETIC ISSUES (B)(6). COSMETIC ISSUES, HAPTIC DAMAGED (B)(6). CARTRIDGE TIP CRACKED/DAMAGED, HAPTIC DAMAGED, HAPTIC DETACHED, IOL TORN (B)(6). HAPTIC DAMAGED, HAPTIC DETACHED, LENS DAMAGED 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THERE ARE 6 INVESTIGATIONS COMPLETED DURING THIS PERIOD. BREAKDOWN OF 6 INVESTIGATIONS WITH RESPECTIVE SERIAL NUMBERS ARE AS FOLLOWS: (B)(6) LENS CUT, HAPTIC DETACHED, LENS DAMAGED; (B)(6) LENS CUT, LENS DAMAGED; (B)(6) COSMETIC ISSUES; (B)(6) NO PRODUCT RETURNED; (B)(6) COSMETIC ISSUES, HAPTIC DAMAGED, LENS DAMAGED; (B)(6) COSMETIC ISSUES, HAPTIC DETACHED. 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> 13 </NOE> MALFUNCTION EVENTS RELATED TO LENS DAMAGED. A REVIEW OF EVENTS INDICATED THAT THE IOL MODEL Z9002 EXPERIENCED LENS DAMAGED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BREAKDOWN OF 24 EVENTS IS AS FOLLOWS: COSMETIC ISSUES, DEVICE PARTIALLY DELIVERED: 1. DEVICE PARTIALLY DELIVERED, HAPTIC DAMAGED: 4. DEVICE PARTIALLY DELIVERED, HAPTIC DAMAGED, STUCK IN CARTRIDGE: 1. DEVICE PARTIALLY DELIVERED, IOL TORN: 1. DEVICE PARTIALLY DELIVERED, IOL TORN, PLUNGER ROD ISSUE: 1. HAPTIC DAMAGED: 9. HAPTIC DAMAGED, STUCK IN CARTRIDGE: 1. HAPTIC DETACHED :1. LENS DAMAGED: 3. LENS DAMAGED, STUCK IN CARTRIDGE: 2. (UDI#): ONLY A PORTION OF THE UDI IS PROVIDED. SERIAL NUMBER OF THE SUSPECT PRODUCT: (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. (B)(4): 1. 16 INVESTIGATION WERE COMPLETED, AND 8 INVESTIGATIONS ARE PENDING FROM THIS PERIOD. BREAKDOWN OF 17 COMPLETED INVESTIGATIONS: (B)(4): LENS CUT, HAPTIC DAMAGED, HAPTIC DETACHED. (B)(4): IOL TORN. (B)(4): LENS CUT, HAPTIC DAMAGED, HAPTIC DETACHED. (B)(4): NO PRODUCT RETURNED. (B)(4): COSMETIC ISSUES, HAPTIC DAMAGED, LENS DAMAGED. (B)(4): NO PRODUCT RETURNED. (B)(4): NO PRODUCT RETURNED. (B)(4): COSMETIC ISSUES, HAPTIC DETACHED. (B)(4): LENS CUT, HAPTIC DAMAGED. (B)(4): LENS CUT. (B)(4): HAPTIC DETACHED, IOL TORN. (B)(4): NO PRODUCT RETURNED. (B)(4): NO PRODUCT RETURNED. (B)(4): NO PRODUCT RETURNED. (B)(4): HAPTIC DAMAGED, LENS DAMAGED. (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> 24 </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
    153093 TECNIS CL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1