BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19662280 · Received July 2, 2024

    Report

    Report Number
    3012236936-2024-000186
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 2, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558274
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4, A5, A6: UNKNOWN/ NOT PROVIDED. ASKU. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER WAS PERFORMED IN THE SYSTEM. THE SEARCH REVEALED ONE COMPLAINT FOLDER. THE COMPLAINT ISSUES REPORTED ARE NOT RELATED. BASED ON COMPLAINT HANDLING REPORT RESULTS, NO FURTHER ACTIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. 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 INTRAOCULAR LENS (IOL) WAS NOT EJECTING. THE SURGEON AND TECH CLAIM THAT THE LENS GOT STUCK WHEN INJECTING. THE DOCTOR USED EXTRA FORCE (MORE PRESSURE) ON PLUNGER AND LENS CAME OUT FORCEFULLY AND BROKE CAPSULE. THE SURGERY WAS FINISHED USING A NON-JOHNSON & JOHNSON LENS OF 18.5 DIOPTER. THE AFFECTED EYE WAS THE RIGHT EYE AND THERE WAS PATIENT CONTACT. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. THE ACCOUNT NOTED IT IS UNKNOWN IF THE PROBLEM RELATED TO USE ERROR. IT IS UNKNOWN IF THE PATIENT HAD A CAPSULE TEAR AND THE PATIENT OUTCOME STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570446 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558274

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other