MAUDE Adverse Event Report: REVISION OPTICS RAINDROP NEAR VISION INLAY; CORNEAL INLAY

Model Number	610-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Keratitis (1944)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted inlay 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.Diffuse lamellar keratitis (dlk) is listed in the device labeling as a known potential risk of corneal inlay surgery and corneal flap procedures created using a femtosecond laser.(b)(4).
Event or Problem Description
The patient underwent implantation of the corneal inlay in the left eye on (b)(6) 2017.The patient was diagnosed with trace diffuse lamellar keratitis 3 days postoperatively; the following day the flap was lifted, and the inlay was removed and replaced with a new inlay.The cause of the dlk is not known at this time.Additional information is being requested.

• Brand Name: RAINDROP NEAR VISION INLAY
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; CA 92630 8835
• MDR Report Key: 7162855
• Report Number: 3005956347-2018-00002
• Device Sequence Number: 1407615
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 05/12/2020
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMTOSECOND LASER
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 50 YR