BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR

    MDR report key: 8280046 · Received January 25, 2019

    Report

    Report Number
    3006695864-2019-00061
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    December 30, 2018
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    LZS
    UDI-DI
    00(01)(21)3129
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED: AT A POST OP VISIT, THE PATIENT WAS PRESENTED WITH WHITE HAZINESS TO RIGHT EYE (OD) VISION. THE PATIENT IS STILL USING PREDNISOLONE. IT WAS ALSO NOTED THERE WAS STROMAL EDEMA AND INTRAOCULAR PRESSURE WAS AT 48. THE SURGERY NOTED, IT IS LIKELY INTRAOCULAR PRESSURE-INDUCED INTERLAMELLAR STROMAL KERATITIS ON THE RIGHT EYE. THE PATIENT¿S CHIEF COMPLAINT WAS OF BLURRED VISION AND WHITE HAZINESS ON OD. THE PATIENT IS EXPERIENCING LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). POST OP REFRACTIVE MEASUREMENTS AS OF 1/30/2019 FOR BCVA IS OD 20/200 AND OS 20/40. ADDITIONAL PATIENT CODES WERE INCLUDED IN THIS FOLLOW UP BASED ON THE FOLLOW UP RECEIVED. PATIENT CODES ARE LISTED IN SECTION FOR HAZE, STROMAL EDEMA, AND KERATITIS H6: ADDITIONAL PATIENT CODE OF 2137 IS PROVIDED FOR BLURRED VISION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: MANUFACTURING DATE - THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS 2/24/1996.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215

    Additional Manufacturer Narrative · 1

    A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2018 AND PRESENTED ON (B)(6) 2018 WITH PAIN IN RIGHT EYE. AFTER EXAMINATION IT WAS DISCOVERED PATIENT HAD ABRASION. THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF PAIN IN RIGHT EYE. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -.75 X -1.00 X 63; LEFT EYE PRE-OP 20/20 -1.50 X -.50 X 111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72254 STAR EXCIMER LASER LZS JOHNSON & JOHNSON SURGICAL VISION, INC 0030-1479 00(01)(21)3129

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention