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 Problems Corneal Scar (1793); Corneal Clouding/Hazing (1878); Loss of Vision (2139)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was returned to the manufacturer, and the investigation is underway.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, decreased vision, and corneal scarring 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.Early in the postoperative period, the patient presented with trace diffuse lamellar keratitis (dlk) and a few red blood cells in the interface that resulted from a hemorrhage during flap creation with the femtosecond laser.The patient was treated successfully with routine topical steroids and the event was not considered serious.It should be noted that celluvisc was used intraoperatively, which may have contributed to the dlk.At some time later in the postoperative period (exact date not known), the patient presented with corneal haze and the patient was treated with topical steroids.Approximately one year postoperatively, the patient presented with recurrent central corneal haze and decreased best corrected distance vision (bcdva) from 20/25+ (preoperatively) to 20/50.The inlay was explanted on (b)(6) 2017.The surgeon reports that a dlk-like inflammation was a contributing factor in the development of corneal haze.The source of the dlk was believed to be related to toxins in the sterile instrument case.At last examination on one-week post explant, the patient's bcdva was 20/50-1 with the presence of a mild scar and haze.Additional information will be requested.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest 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: 7113786
• MDR Text Key: 94732020
• Report Number: 3005956347-2017-00154
• 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: 12/13/2017

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: 08/08/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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