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); Loss of Vision (2139)

Event Date 09/14/2017

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 and the inlay was clear and did not have a cloudy appearance.Surface damage (tears and 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.Corneal haze is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.Eight months postoperatively the inlay was explanted to address corneal haze and inlay fibrosis.Additional information has been requested to understand the type of haze and impact on vision.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.Inlay implantation was uneventful and lasik surgery was performed in the operative eye concurrent with inlay implantation.The surgeon clarified that the primary reason for inlay removal was to perform lasik enhancement, however, prior to explant the patient had 1+ corneal haze and bcdva had decreased from 20/20 (preoperatively) to 20/30- at onset, improving to 20/25- immediately prior to explantation.At last examination on (b)(6) 2017 the corneal haze resolved, however bcdva decreased to 20/60.The surgeon reports that early discontinuation of durezol (non-compliance) may have been a contributing factor.Additional information has been requested.

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

Patient follow-up was requested and the following additional information was received.At last examination on (b)(6) 2017 the patient's distance vision has improved.The best corrected distance vision (bcdva) was not measured but the uncorrected distance vision (ucdva) was 20/30.

• 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: 6949459
• MDR Text Key: 89362537
• Report Number: 3005956347-2017-00120
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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: 10/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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: 50 YR