BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 7089176 · Received December 6, 2017

    Report

    Report Number
    3005956347-2017-00151
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 20, 2017
    Report Date
    January 4, 2018
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS DISCARDED BY THE FACILITY AND IS 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 NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    CORNEAL SCARRING IS LISTED IN THE DEVICE LABELING AS A KNOWN POTENTIAL RISK. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY ON (B)(6) 2017. ON (B)(6)2017, THE INLAY WAS EXPLANTED IN ORDER TO ADDRESS RECURRENT CORNEAL HAZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE FOLLOWING NEW INFORMATION WAS PROVIDED BY THE SURGEON. THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2017. ON (B)(6) 2017 A MINOR SCAR WAS OBSERVED ON THE CENTRAL CORNEA. ON (B)(6) 2017, THERE WAS NO SCARRING VISIBLE, BUT THERE WAS PERIPHERAL EDGE HAZE. THE INLAY WAS EXPLANTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868642 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 003045 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention