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

Model Number 600-0032

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

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

The site is being contacted to clarify whether the device is available for evaluation.The review of the device history record is underway and will be reported in a follow-up report.Corneal haze is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The subject was enrolled in a foreign clinical trial and underwent uneventful implantation of the investigational raindrop corneal inlay in the right eye on (b)(6) 2016.The study involved the use of a corneal pocket for implantation of the inlay.Six months postoperatively the patient presented with faint central corneal haze that recurred 9 months postoperatively and again 12 months postop.Immediately prior to explant on (b)(6) 2017, the central corneal haze was graded as faint.The surgeon believes that extended debris in the corneal pocket contributed to the development of haze.The haze did not result in a clinically significant decrease in best corrected distance visual acuity (bcdva).The patient is scheduled for examination 1-month and 3-months post inlay removal.

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.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 (dhr) review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Complaint reference number: (b)(4).

Event Description

Rvo received the following additional information.The patient has been deemed lost to follow-up after serveral attempts to bring the patient back.

• 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: 6963471
• MDR Text Key: 89808033
• Report Number: 3005956347-2017-00126
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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: 07/01/2017
• Device Model Number: 600-0032
• Device Lot Number: 002627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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: 50 YR