BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAINDROP NEAR VISION INLAY

    MDR report key: 6126255 · Received November 23, 2016

    Report

    Report Number
    3005956347-2016-00006
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 28, 2016
    Report Date
    August 31, 2017
    Manufacturer
    REVISION OPTICS
    Product Code
    LQE
    UDI-DI
    10850394006013
    PMA / PMN Number
    P150034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REFERENCE NUMBER: (B)(4). DATE ESMDR SUBMITTED: 01/13/2017.

    Additional Manufacturer Narrative · 1

    DUE TO SUSPECTED INFECTIOUS KERATITIS, THE SURGEON SENT THE EXPLANTED INLAY TO A LABORATORY FOR CULTURING. THE EXPLANTED INLAY WAS SUBJECTED TO MICROBIOLOGICAL TESTING AND THE AEROBIC CULTURE SHOWED NO GROWTH AFTER TWO DAYS, THEREBY RULING OUT THE INLAY AS A POSSIBLE SOURCE OF INFECTION. THE DEVICE HISTORY RECORD (DHR) 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. DIFFUSE LAMELLAR KERATITIS (DLK) IS LISTED IN THE DEVICE LABELING AS A KNOWN COMPLICATION OF CORNEAL INLAY SURGERY AND IS COMMONLY ASSOCIATED WITH CORNEAL FLAP PROCEDURES CREATED USING A FEMTOSECOND LASER. THE OFF-LABEL USE OF CELLUVISC MAY HAVE BEEN CONTRIBUTORY. THE HAZE OBSERVED ON THE INLAY WAS THOUGHT TO BE SECONDARY TO KERATITIS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON DECEMBER 15, 2016. IMMEDIATELY PRIOR TO EXPLANTATION OF THE CORNEAL INLAY, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) HAD DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/400 DUE TO STAGE 3 DIFFUSE LAMELLAR KERATITIS. CONFLUENT DLK WAS OBSERVED OVER THE INLAY, BUT THE LIDS AND LASHES WERE NORMAL. POST EXPLANTATION BCDVA IMPROVED TO 20/100, BUT CENTRAL CORNEAL SCARRING (2 MM) WITH MILD ANTERIOR SUB-EPITHELIAL CYSTIC CHANGES WAS NOTED.

    Description of Event or Problem · 1

    CORNEAL INLAY IMPLANTATION WAS PERFORMED ON (B)(6) 2016 ON THE PATIENT'S RIGHT EYE. DURING THE FLAP PORTION OF THE PROCEDURE, THE PATIENT REPORTED EXPERIENCING PAIN AND THE EYE WAS RE-DOCKED 3 TIMES; THE PATIENT ALSO REPORTED PAIN WITHIN THE FIRST FEW HOURS FOLLOWING SURGERY. AT THE END OF THE PROCEDURE, SEVERAL DROPS OF CELLUVISC WERE INSTILLED ON THE TOP OF THE FLAP. AT THE ONE-DAY POSTOPERATIVE VISIT, THE PATIENT COMPLAINED OF BLURRY VISION AND THE CONJUNCTIVA WAS RED AND SWOLLEN. THE PATIENT WAS DIAGNOSED WITH DIFFUSE LAMELLAR KERATITIS (DLK), GRADE 2, WITH HAZE OBSERVED ON THE SUPERIOR TEMPORAL EDGE OF THE CORNEAL INLAY (COVERING APPROXIMATELY 1/4TH OF THE INLAY). THE POSTOPERATIVE STEROID REGIMEN (DUREZOL) WAS INCREASED TO EVERY 2 HOURS. AT THE 4-DAY POSTOPERATIVE VISIT ON (B)(6) 2016, MOST OF THE DLK HAD MIGRATED TO THE AREA OF THE INLAY AND THE INLAY WAS OPAQUE. THE INLAY WAS SUBSEQUENTLY EXPLANTED. DUREZOL DOSAGE WAS FURTHER INCREASED TO EVERY HOUR. THE SURGEON SUSPECTED INFECTIOUS KERATITIS AND SENT THE EXPLANTED INLAY OUT TO A LABORATORY FOR ANALYSIS.

    Description of Event or Problem · 1

    PATIENT FOLLOW-UP WAS REQUESTED AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS LAST EXAMINED ON (B)(6) 2017. DURING THIS EXAM, CENTRAL CORNEAL SCAR WAS OBSERVED AND THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/40. IT WAS DECIDED TO WAIT FOR 2-4 MONTHS TO SEE IF CORNEAL SCAR MATURES AND DO A RGP CONTACT LENS OVER-REFRACTION. CORNEAL TRANSPLANT (DALK) WAS INDICATED IF VISUAL ACUITY DID NOT IMPROVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775227 RAINDROP NEAR VISION INLAY CORNEAL INLAY LQE REVISION OPTICS 610-0001 002979 10850394006013

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CELLUVISC ARTIFICIAL TEARS| FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP