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

Model Number 610-0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Clouding/Hazing (1878); Visual Disturbances (2140)

Event Date 08/28/2017

Event Type  Injury  

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.Tears, cuts, and debris were observed on the surface of the inlay, 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.Corneal haze and visual disturbances are listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent implantation of the corneal inlay in the right eye on (b)(6) 2016.Four months postoperatively the patient presented with an inflammatory response in the operative eye.The inlay was explanted on (b)(6) 2017 due to intolerable visual disturbances and chronic mild corneal haze around the inlay.The patient's preoperative best corrected distance visual acuity (bcdva) was 20/20, decreasing to 20/25 immediately prior to explant.The surgeon attributed the event to the patient's wound healing response.Bcdva has not been measured post explant.Additional information will be requested.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS, INC.; 25651 atlantic ocean drive; suite a1; lake forest CA 92630 8835
• Manufacturer (Section G): REVISION OPTICS, INC.; 25651 atlantic ocean drive; suite a1; lake forest CA 92630 8835
• Manufacturer Contact: pushpita singh ; 25651 atlantic ocean drive; suite a1; lake forest, CA 92630-8835 ; 9497072740
• MDR Report Key: 6898218
• MDR Text Key: 87612967
• Report Number: 3005956347-2017-00112
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2017

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
• Device Operator: Physician
• Device Expiration Date: 08/01/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR