BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6950193 · Received October 13, 2017

    Report

    Report Number
    3005956347-2017-00121
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    September 15, 2017
    Report Date
    November 29, 2017
    Manufacturer
    REVISION OPTICS, INC.
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS LOST BY THE USER FACILITY AND WAS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD REVIEW OF THE MANUFACTURING LOT WAS PERFORMED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. CORNEAL HAZE IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. COMPLAINT REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THERE WERE NO COMPLICATIONS DURING SURGERY TO IMPLANT THE INLAY AND THE PATIENT HAD NO PRE-EXISTING CONDITIONS. THE FIRST ONSET OF CORNEAL HAZE WAS ON (B)(6) 2017 AND THE HAZE PERSISTED UNTIL THE INLAY WAS EXPLANTED. AT LAST EXAMINATION THE PATIENT'S BCDVA RETURNED TO BASELINE (20/20) AND THE HAZE RESOLVED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE INLAY WAS EXPLANTED 10 MONTHS POSTOPERATIVELY TO ADDRESS 1-2+ CORNEAL HAZE. AT ONSET, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY HAD DECREASED FROM 20/20 PREOPERATIVELY TO 20/30-2. PRIOR TO INLAY EXPLANT, THE PATIENT WAS TREATED WITH TOPICAL STEROIDS WITH BCDVA IMPROVING TO 20/25. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726958 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS, INC. 610-0001 002984 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention