BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6194666 · Received December 21, 2016

    Report

    Report Number
    3005956347-2016-00012
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 21, 2016
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INLAY WAS NOT RETURNED TO THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR THIS MANUFACTURING LOT WAS REVIEWED AND THE DEVICE MET ALL RELEASE CRITERIA AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. CORNEAL HAZE AND INLAY REMOVAL ARE LISTED IN THE DEVICE LABELING AS KNOWN COMPLICATIONS OF CORNEAL INLAY SURGERY. (B)(4). DATE EMDR SUBMITTED TO FDA: 12/21/2016.

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. PRIOR TO EXPLANTATION OF THE CORNEAL INLAY, THE PATIENT PRESENTED WITH TRACE CENTRAL CORNEAL HAZE AND GRADE 1 PERIPHERAL EDGE HAZE THAT RESULTED IN A DECREASE IN BCDVA FROM 20/16 PREOPERATIVELY TO 20/32-2. THE PATIENT HAD PRE-EXISTING DRY EYE SYNDROME IN THE OPERATIVE EYE. POST EXPLANTATION, THE CORNEAL HAZE RESOLVED AND BCDVA RETURNED TO BASELINE. THE PATIENT'S MOST RECENT BCDVA IMPROVED TO 20/16-2.

    Description of Event or Problem · 1

    THE CORNEAL INLAY WAS BEING STUDIED INVESTIGATIONALLY IN (B)(6) AND THE SUBJECT UNDERWENT IMPLANTATION OF THE CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. FOUR MONTHS POSTOPERATIVELY, THE SUBJECT PRESENTED WITH CENTRAL CORNEAL HAZE IN THE OPERATIVE EYE AND THE INLAY WAS EXPLANTED. THE HAZE RESOLVED AFTER EXPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845689 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 002627

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP| METAMYCIN