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	Loss of Vision (2139)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The edge thickness and diameter were measured and found to be within specifications.Cuts and particles were observed on the device, but these findings are consistent with findings for corneal inlays that have been explanted since surgical instruments are required to remove the device from the eye and place it in a hydrated storage container for transport.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Decreased visual acuity is listed in the device labeling as a known potential risk.(b)(4).
Event or Problem Description
The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.The inlay was explanted on (b)(6) 2017 in order to address decreased best corrected distance visual acuity (bcdva) from 20/15 (preoperatively) to 20/40+2.Post explant, bcdva improved to 20/30.The reason for decreased vision remains unknown.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Patient follow-up was requested from the surgeon, who provided the following additional information.The patient was last examined on (b)(6) 2017 and the best corrected distance visual acuity (bcdva) had improved to 20/20-1.

• 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: 7148558
• Report Number: 3005956347-2017-00167
• Device Sequence Number: 1238135
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: 09/16/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention