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

Model Number 610-0001

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

Patient Problem Loss of Vision (2139)

Event Date 10/20/2017

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.The inlay was received in a dehydrated state with small cuts and particles and some light brown residue observed on the surface.The light residue came off once the inlay was rehydrated.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 storage container for transport.It should be noted that the device was not properly stored during transport and it was received in a non-hydrated state.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.Complaint reference number: (b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the left eye (b)(6) 2017.The inlay was explanted on (b)(6) 2017 due to decreased best corrected distance visual acuity (bcdva) from 20/20 (preoperatively) to 20/30 prior to explant.Post inlay explantation, bcdva returned to 20/20.The cause of the decreased vision remains unknown.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; CA 92630 8835
• Manufacturer (Section G): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest CA 92630 8835
• Manufacturer Contact: pushpita singh ; 25651 atlantic ocean dr.,; ste a1; lake forest, CA 92630-8835 ; 9497072740
• MDR Report Key: 7149722
• MDR Text Key: 95897404
• Report Number: 3005956347-2017-00169
• 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: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 12/02/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• 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): Life Threatening; Required Intervention
• Patient Age: 45 YR