BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7019045 · Received November 10, 2017

    Report

    Report Number
    3005956347-2017-00138
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 13, 2017
    Report Date
    December 27, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT FOR THIS DEVICE WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. CORNEAL HAZE, HALOS, AND GLARE ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. ADDITIONAL INFORMATION: COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IDENTIFIERS HAVE BEEN REQUESTED. CORNEAL INFLAMMATION IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PROCEDURE TO IMPLANT THE CORNEAL INLAY IN THE PATIENT'S LEFT EYE WAS UNEVENTFUL. CORNEAL HAZE WAS FIRST OBSERVED AT THE ONE-MONTH POSTOPERATIVE VISIT WITH RECURRENCES OF MILD HAZE AT 4 AND 5 MONTHS POSTOPERATIVELY. PRIOR TO EXPLANTATION OF THE CORNEAL INLAY, THE CORNEAL HAZE PROGRESSED TO GRADE 3+, LOCATED IN THE AREA OF THE INLAY. THE CORNEAL HAZE WAS ASSOCIATED WITH SIGNIFICANT HALOS AND GLARE THAT IMPACTED THE PATIENT'S ABILITY TO DRIVE. IN ADDITION, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/50 (IMMEDIATELY PRIOR TO INLAY EXPLANTATION). POST INLAY EXPLANT, THE CORNEAL HAZE AND HALO/GLARE SYMPTOMS RESOLVED AND BCDVA IMPROVED TO 20/25-2.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY (DATE UNKNOWN). THE INLAY WAS EXPLANTED ON (B)(6) 2017 DUE TO CORNEAL INFLAMMATION. THE SERIOUSNESS OF THE INFLAMMATION AND IMPACT ON VISION ARE NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799118 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 003007 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention