BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16313434 · Received February 7, 2023

    Report

    Report Number
    3012236936-2023-00275
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    December 14, 2022
    Report Date
    June 7, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731745
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED DATA: BASED ON FURTHER INVESTIGATION AND THE CLARIFICATION RECEIVED FROM THE CUSTOMER, THERE WERE NO LENS ISSUES IDENTIFIED. THE LENS MET THE REQUIRED SPECIFICATIONS. THEREFORE, THE EVENT IS NO LONGER CONSIDERED AS REPORTABLE AND NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER PLEASE NOTE THAT THE INFORMATION REPORTED IN SECTIONS D2 (COMMON DEVICE NAME), H.6 (HEALTH EFFECT -CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE) AND SECTION G.1 (MANUFACTURER CONTACT E-MAIL) IS INFORMATION THAT REMAINS UNCHANGED FROM THE INITIAL EMDR REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED AN INTRAOCULAR LENS (IOL) WILL BE EXPLANTED FROM A PATIENT¿S RIGHT EYE (OD) AND FORECAST EXPLANT IN TWO WEEKS WITH NO SPECIFIC DATE WAS INDICATED. IT WAS REPORTED THAT THE PATIENT HAD POOR BLURRY VISION, POOR VISUAL ACUITY POST OPERATION DAY-1 OF 20/600. BELOW ARE THE PATIENT¿S VISUAL ACUITY AND REFRACTION MEASUREMENTS: ON (B)(6) 2022 - 20/600 PO1D (POST OPERATIVE 1 DAY). ON (B)(6) 2022 - RX - AR +5.50 +6 REFRACT TO 20/25 1/4 - 20/500 + 5.75 + 6 = 20/25. ON (B)(6) 2022 VA (VISUAL ACUITY) 20/50 (STILL DILATED). THE DOCTOR REPORTED THAT THE PATIENT REFRACTED TO 20/25 WITH +6.00 SPHERE ONE-WEEK POST-OP WITH NO CORNEAL EDEMA. HIS INITIAL IOL MASTER READING SUGGESTED THAT 19.5 WOULD LEAVE HIM AT -0.15. AXIAL LENGTH WAS 24.49MM OD WHICH WAS VERY SIMILAR TO HIS LEFT EYE 24.39MM LEFT EYE (OS). FOR THE RIGHT EYE, THE PATIENT¿S K READING WERE FAIRLY NORMAL K1 42.13 AND K2 43.48 AND FOR HIS LEFT EYE THE K READINGS WERE K1 41.98 K2 43.32. THERE WAS NO HISTORY OF PREVIOUS EYE SURGERY SUCH AS REFRACTIVE SURGERY AND NO PRE-EXISTING MEDICAL ISSUES REPORTED. THE PATIENT¿S CATARACT WAS NOT VERY DENSE, AND HIS CASE HAD NO COMPLICATIONS. THE DOCTOR INDICATED THAT ALL THE MEASUREMENTS AND INFORMATION THAT HE HAD AVAILABLE SUGGEST THAT THE 19.5D LENS WOULD HAVE BEEN FINE AND HAD CONCERNS WITH THE IOL POWER. ADDITIONALLY, IT WAS REPORTED THAT THE LENS WAS EXPLANTED ON (B)(6) 2023. IOL MASTER DONE POST-OP WEEK# 1 SUGGESTED THAT 20.0 DIOPTER (D) IOL WOULD RESULT IN -0.15. THEREFORE, THE DOCTOR USED SAME MODEL, BUT DIFFERENT DIOPTER (20.0 D) AS THE REPLACEMENT LENS. THERE WAS NO VITRECTOMY PERFORMED, NO COMPLICATION REPORTED, AND NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT¿S OUTCOME POST-OP DAY-1 WAS 20/50 AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204580 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731745

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention