BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6962559 · Received October 19, 2017

    Report

    Report Number
    3005956347-2017-00124
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 21, 2017
    Report Date
    December 22, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE IS BEING CONTACTED TO CLARIFY WHETHER THE DEVICE IS AVAILABLE FOR EVALUATION. THE REVIEW OF THE DEVICE HISTORY RECORD IS UNDERWAY AND WILL BE REPORTED IN A FOLLOW-UP REPORT. CORNEAL HAZE IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. COMPLAINT REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE MANUFACTURING LOT FOR THIS DEVICE WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE SUBJECT WAS ENROLLED IN A FOREIGN CLINICAL TRIAL AND UNDERWENT IMPLANTATION OF THE INVESTIGATIONAL RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE STUDY INVOLVED THE USE OF MITOMYCIN-C AND CONCURRENT LASIK IN THE OPERATIVE EYE. SIX MONTHS POSTOPERATIVELY THE PATIENT PRESENTED WITH FAINT CENTRAL CORNEAL HAZE THAT RECURRED 9 MONTHS POSTOPERATIVELY AND AGAIN 15 MONTHS POSTOP. IMMEDIATELY PRIOR TO EXPLANT ON (B)(6) 2017, THE CORNEAL HAZE WAS CENTRAL, GRADE 1/TRACE. THE SURGEON BELIEVES THAT EXTENDED DEBRIS IN THE CORNEAL FLAP CONTRIBUTED TO THE DEVELOPMENT OF HAZE. BEST CORRECTED DISTANCE VISUAL ACUITY WAS NOT MEASURED AT THE ONSET OF CORNEAL HAZE OR IMMEDIATELY PRIOR TO INLAY EXPLANT, SO THE IMPACT ON VISION IS UNABLE TO BE CHARACTERIZED. THE PATIENT IS SCHEDULED FOR EXAMINATION AT 1-MONTH AND 3-MONTHS POST INLAY REMOVAL.

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED AND THE FOLLOWING INFORMATION WAS RECEIVED. AT 3-MONTHS POST INLAY EXPLANT VISIT, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/20 AND THE CORNEAL HAZE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740776 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 600-0032 002627

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention