BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6967252 · Received October 20, 2017

    Report

    Report Number
    3005956347-2017-00128
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    January 17, 2018
    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 EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THOROUGH MICROSCOPIC INSPECTION REVEALED THERE WAS NO INLAY INSIDE THE CONTAINER AND NO FURTHER ANALYSIS COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SITE IS BEING CONTACTED TO CLARIFY WHETHER THE DEVICE IS AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. CORNEAL HAZE, HALOS, AND DOUBLE VISION ARE LISTED IN THE DEVICE LABELING AS KNOWN POTENTIAL RISKS. (B)(4).

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED FROM THE STUDY PERSONNEL, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. AT LAST EXAMINATION ON (B)(6) 2017, THE VISUAL DISTURBANCES (HALOS/DOUBLE VISION) HAD RESOLVED AND BCDVA RETURNED TO BASELINE (20/16) WITH PERSISTENT TRACE CENTRAL CORNEAL HAZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE SUBJECT WAS ENROLLED IN A FOREIGN CLINICAL TRIAL AND UNDERWENT UNEVENTFUL IMPLANTATION OF THE INVESTIGATIONAL RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2017. THE INLAY WAS EXPLANTED 5 WEEKS POSTOPERATIVELY TO ADDRESS FAINT CENTRAL CORNEAL HAZE. THE PATIENT ALSO REPORTED EXPERIENCING MODERATE HALOS AND MARKED DOUBLE VISION. THE SURGEON BELIEVES THAT EXTENDED DEBRIS IN THE FLAP INTERFACE CONTRIBUTED TO THE DEVELOPMENT OF HAZE. THE HAZE DID NOT RESULT IN A CLINICALLY SIGNIFICANT DECREASE IN BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA). THE PATIENT IS SCHEDULED FOR EXAMINATION 1-MONTH AND 3-MONTHS POST INLAY REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745169 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 606-0001 003080

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention