BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDESIGN AWS SYSTEM

    MDR report key: 8771036 · Received July 9, 2019

    Report

    Report Number
    3006695864-2019-00559
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    April 18, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    GEX
    UDI-DI
    05050474573437
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    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-(B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). A FIELD SERVICE ENGINEER VISITED THE CUSTOMER TO CHECK THE DEVICE. NO FAILURE DETECTED. MACHINE MET SPECIFICATIONS. IN ADDITION, A JOHNSON & JOHNSON CLINICAL MONITOR CONSULTANT REVIEWED THE TREATMENT PLAN AND FOUND THE EXAMINATION OF THE DESIGN TREATMENT PLANS SHOWS GOOD QUALITY SCANS WITH THREE GREEN SIGNS IN STATUS (IRIS REGISTRATION, WAVEFRONT, AND CORNEA), REASONABLY GOOD MATCH BETWEEN MANIFEST REFRACTIONS, HOWEVER, NOTED THE OPTICAL ZONES (OZ) AND ABLATION ZONES(AZ) HAVE BEEN ENLARGED. THIS ENLARGEMENT OF OZ AND AZ HAS PRODUCED AN ABLATION DEEPER THAN RECOMMENDED. THERE WAS A WARNING IN BOTH EYES REGARDING THE ABLATION LIMIT OF 150 MICRONS NOT BEING FOLLOWED. ACCORDING TO THE MUNNERLYN FORMULA, WHEN YOU INCREASE OZ, THE DEPTH OF THE ABLATION INCREASES EXPONENTIALLY, BECOMING UNPREDICTABLE AND INDUCING A LIKELY OVERCORRECTION. THE CONSULTANT FOUND THE DIFFERENCE BETWEEN THE RECOMMENDED ABLATION AND THE ACTUAL ABLATION AND INCREASING THE OZ EXPLAINS THE OVERCORRECTION OBSERVED IN THE CASE. THE J&J CONSULTANT PROVIDED CONTACT INFORMATION TO THE TREATING SURGEON TO DISCUSS THE TREATMENT CASE AND PROVIDE AWARENESS. 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A CUSTOMVUE MYOPIC TREATMENT ON (B)(6) 2019 WHERE THE PATIENT PRESENTED HIGH OVERCORRECTION AND REMARKABLE CORNEAL DISABILITY, CORNEAL THICKNESS RESULTED MUCH MORE REDUCTED COMPARED TO THE BASELINE. UP TO THIS MOMENT A RE-TREATMENT FOR THE PATIENT IS NOT PLANNED. HOWEVER PATIENT IS STILL HYPEROPIC. PREOPERATIVE TOPOGRAPHY APPEARED NORMAL AND REGULAR IN BOTH EYES WITH CENTRAL CORNEAL THICKNESS OF 575 AND 573 MICRONS RESPECTIVELY. POSTOPERATIVE CORNEAL TOPOGRAPHIES SHOWED A WELL CENTRED MYOPIC ABLATION WITH CENTRAL CORNEAL THICKNESS OF 344 MICRONS OD AND 343 MICRONS . ALL INFORMATION AVAILABLE HAVE BEEN SUBMITTED. PRE OP REFRACTION : VOD: 8-9/10 -7.00 SF VOS: 9-10/10 -6.25 SF -0.25 CYL 58°. POST OP REFRACTION: VOD: 8-9/10 +2.50 SF VOS: 9-10/10 +2.50 SF. THIS REPORT IS FOR THE WAVESCAN. A SEPARATE REPORT WILL BE SUBMITTED FOR EXCIMER LASER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567231 IDESIGN AWS SYSTEM REFRACTIVE MEASUREMENT GEX JOHNSON & JOHNSON SURGICAL VISION, INC. 0110-0001 05050474573437

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other EXCIMER LASER SERIAL NO. (B)(4)