BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17452308 · Received August 3, 2023

    Report

    Report Number
    3012236936-2023-01971
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 22, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636002
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: NA, THERE WAS NO PATIENT CONTACT. SECTION D6B: NA, THERE WAS NO PATIENT CONTACT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: (B)(6) 2023. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: PRODUCT EVALUATION WAS PERFORMED UNDER MAGNIFICATION. THE COMPLAINT LENS WAS RECEIVED CUT IN HALF. ONE HALF HAD AN INTACT HAPTIC WHICH WAS MEASURED AND WAS FOUND TO BE IN SPECIFICATION. A DETACHED HAPTIC WAS RECEIVED AS WELL. THE COMPLAINT HANDPIECE WAS INSPECTED AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER ISSUE OBSERVED DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. AS PER COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MONOFOCAL PRELOADED INTRAOCULAR LENS HAPTICS WERE AMPUTATED AND WOULD NOT BE VIABLE FOR PATIENTS. THROUGH FOLLOW-UP, WE LEARNED THAT IT WAS ONLY THE INJECTOR WHICH TOUCHED THE EYE. NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658361 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636002

    Patients

    Seq Age Sex Outcome Treatment
    1 Female