BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11211293 · Received January 21, 2021

    Report

    Report Number
    2648035-2021-07132
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    December 1, 2020
    Report Date
    January 21, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE OF EVENT UNKNOWN, NOT PROVIDED. (B)(6) 2020 PROVIDED AS A BEST ESTIMATE. SERIAL NUMBER: INFORMATION UNKNOWN/NOT PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: INFORMATION UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. PHONE NUMBER: (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: MANUFACTURING RECORD REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. A HISTORICAL REVIEW CANNOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: NO SAMPLE WAS RETURNED, AND THE SERIAL NUMBER IS UNKNOWN AN INVESTIGATION COULD NOT BE PERFORMED, AND NO MALFUNCTION IS CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRAILING HAPTIC WAS STUCK ON THE OPTICAL PART OF THE LENS WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE PHYSICIAN TRIED TO UNSTUCK THEM USING A HOOK FOR ABOUT 15 MINUTES WITH NO LUCK. AFTER WASHING WITH IRRIGATION/ASPIRATION (I/A), THE LEAD HAPTIC HIT THE CRYSTALLINE LENS CAPSULE WITH A LOT OF MOMENTUM AND THE CILIARY ZONULE WAS REMOVED WHICH LEAD TO THE CAPSULE TEAR AND THE VITREOUS CAME OUT. IT WAS TREATED USING SCISSORS AND MQA (WATER-ABSORBING SPONGE FOR OPHTHALMOLOGY). THE EYE WAS CONTRACTED USING OVISOT (MIOTIC AGENT) AND THE INCISION WAS CLOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A VITRECTOR WAS NOT USED IN VITREOUS TREATMENT. NO OTHER PROBLEMS SUCH AS EYESIGHT ISSUES HAVE BEEN REPORTED. THE LENS REMAINS IMPLANTED AND NO OTHER HEALTH HAZARD ISSUE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102764 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention