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 Codes	Loss of Vision (2139); Visual Disturbances (2140)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted inlay is not available for evaluation.The device history record review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Decreased vision and ghost images are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).
Event or Problem Description
The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2016.The inlay was explanted on (b)(6) 2017 in order to address intolerable visual disturbances (ghost images) and decreased patient's best corrected distance visual acuity (bcdva) from 20/20 (preoperatively) to 20/60 immediately prior to explant.The surgeon reports the image ghosting has resolved and the patient is doing great.Additional information is being requested to obtain the post-explant bcdva.

• 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: 7148351
• Report Number: 3005956347-2017-00164
• Device Sequence Number: 1890272
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P150034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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: 09/16/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002999
• 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: 11/27/2017
• Initial Report FDA Received Date: 12/27/2017
• 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
• Patient Age: 55 YR