BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 11768732 · Received May 4, 2021

    Report

    Report Number
    3006695864-2021-07622
    Event Type
    Injury
    Date Received
    May 4, 2021
    Report Date
    May 14, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    00(01)(21)3206
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING DATE - THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS 03/25/1997. ADDITIONAL INFORMATION: DEVICE EVALUATED BY MANUFACTURER? YES. TYPE OF INVESTIGATION CODES 3331, 4110 AND 4109. INVESTIGATION FINDINGS - CODE 213. DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUAL, TRENDING, AND RISK DOCUMENTATION REVIEWS FOR THIS EQUIPMENT WERE PERFORMED. EQUIPMENT LABELING PROVIDES POSSIBLE COMPLICATIONS THAT CAN BE CAUSED BY THE SURGICAL/TREATMENT PROCEDURE BEING PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN, NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. INITIAL REPORTER PHONE NUMBER: UNKNOWN/NOT PROVIDED. 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. (B)(4). CITATION: LEE, M. D., CHEN, L., TRAN, E., & MANCHE, E. (2020). A PROSPECTIVE COMPARISON OF WAVEFRONT-GUIDED LASIK VERSUS WAVEFRONT-GUIDED PRK AFTER PREVIOUS KERATOREFRACTIVE SURGERY. CLINICAL OPHTHALMOLOGY, VOLUME 14, 3411¿3419. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: A PROSPECTIVE COMPARISON OF WAVEFRONT-GUIDED LASIK VERSUS WAVEFRONT-GUIDED PRK AFTER PREVIOUS KERATOREFRACTIVE SURGERY. SUMMARY: A PROSPECTIVE STUDY WAS DONE TO COMPARE THE RESULTS OF RETREATMENT WITH WAVEFRONT GUIDED LASIK VERSUS WAVEFRONT-GUIDED PRK FOR RESIDUAL REFRACTIVE ERROR FOLLOWING PREVIOUS MYOPIC KERATOREFRACTIVE SURGERY. THIRTY-TWO EYES OF 28 PATIENTS AFTER PRIOR MYOPIC KERATOREFRACTIVE SURGERY UNDERWENT RETREATMENT WITH FLAP-LIFT WAVEFRONT-GUIDED LASIK (N = 12) OR WAVEFRONT-GUIDED PRK (N = 20) FOR RESIDUAL REFRACTIVE ERROR. WAVEFRONT ABERROMETRY WAS PERFORMED USING THE VISX CUSTOMVUE WAVESCAN ABERROMETER AND MEASURED WITH AN UNDILATED PUPIL. SURGERIES WERE PERFORMED BY A SINGLE SURGEON AT A SINGLE FACILITY USING THE AMO VISX S4 CUSTOMVUE IR EXCIMER LASER. ONE EYE WITH PREVIOUS LASIK SURGERY WHICH UNDERWENT LASIK RETREATMENT HAD EPITHELIAL INGROWTH THAT WAS DETECTED AND REMOVED AT THE POST-OPERATIVE MONTH 1 VISIT WITHOUT COMPLICATION OR RECURRENCE. THERE WERE NO OTHER NOTABLE SIGNIFICANT OR ADVERSE EVENTS DURING OR AFTER THE RETREATMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667245 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC 0030-1479 00(01)(21)3206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention