BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16812945 · Received April 26, 2023

    Report

    Report Number
    3012236936-2023-00832
    Event Type
    Injury
    Date Received
    April 26, 2023
    Report Date
    June 30, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731806
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS TO CORRECT THE INITIAL SUBMISSION SECTION B5 DESCRIBE EVENT OR PROBLEM. IT DID NOT MENTION THAT AN EXPLANT MAY HAVE OCCURRED. THE DESCRIPTION SHOULD HAVE INCLUDED THE FOLLOWING. SECTION B5 DESCRIBE EVENT OR PROBLEM: THE ACCOUNT EXECUTIVE STATED THAT ONE OF THE TWO EVENTS WAS EXPLANTED. DUE TO THE LACK OF DETAILS THIS EVENT WAS PROCESSED AND REPORTED AS AN EXPLANT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    RECEIVED ADDITIONAL INFORMATION FROM THE DOCTOR WHO EXPLAINED THAT THE DEFECTS ON THE IOL HAVE BEEN PERIPHERAL AND DEEMED VISUALLY INSIGNIFICANT. THIS IOL IS PROBABLY STILL IN THE EYE. THERE WAS 1 THAT HAD TO BE EXPLANTED DUE TO A MORE SERIOUS SCUFF MARK FROM THE INJECTOR. NO FURTHER INFORMATION WAS PROVIDED. NOTE. DUE TO THE DOCTOR IS UNCERTAIN IF THE IOL IS STILL IN THE EYE THEN THIS EVENT WILL REMAIN AS AN EXPLANT. THE CONFIRMED EXPLANT MENTIONED BY THE DOCTOR WAS REPORTED TO THE FDA IN MEDWATCH 3012236936- 2023- 00833. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A, PATIENT INFORMATION: A2, A4, A5: UNKNOWN/NOT PROVIDED. SECTION B3 DATE OF EVENT: THE EXACT DATE IS UNKNOWN. THE BEST ESTIMATE IS ON OR PRIOR TO THE REPORTING DATE OF MARCH 29, 2023. SECTION D6A, IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE VERIFIED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Description of Event or Problem · 0

    THE ACCOUNT EXECUTIVE STATED THAT ONE OF THE TWO EVENTS WAS EXPLANTED. DUE TO THE LACK OF DETAILS THIS EVENT WAS PROCESSED AND REPORTED AS AN EXPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE LENS THE DOCTOR NOTICED THE IOLS WERE BEING SCUFFED OR SCRATCHED ON THE POSTERIOR SURFACE. REPORTEDLY, THE ISSUE HAS OCCURRED REGULARLY FOR A YEAR NOW. THE SCUFFS ARE LIKE WHEN YOU HAVE BLACK SOLED SHOES THAT ARE RUBBED AGAINST THE FLOOR LEAVING A SCUFF. DR. THINKS THE POSTERIOR OF THE LENS IS BEING TOUCHED. THE CUSTOMER HAS TRIED CHANGING SEVERAL VARIABLES TO RESOLVE THE ISSUE. THEY¿VE USED OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND BALANCED SALT SOLUTION (BSS) TO REMEDY THE SITUATION TO NO AVAIL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667784 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention