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

Model Number PP6-530-0027-US

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

Patient Problems Corneal Clouding/Hazing (1878); Loss of Vision (2139); Visual Disturbances (2140); Halo (2227)

Event Type  Injury  

Manufacturer Narrative

The inlay remains implanted at the time of this report and is therefore not available for evaluation.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 increased visual symptoms are listed in the device labeling as known potential risks.(b)(4).

Event Description

The subject was enrolled in the ide clinical trial and underwent implantation of the investigational corneal inlay in the right eye on (b)(6) 2013.Six months postoperatively, the patient presented with grade 2 central corneal haze in the operative eye, with recurrent haze throughout the course of the study.The haze was associated with visual disturbances (halos, glare, double vision, and ghost images) that significantly interfered with the activities of daily living, including driving at night and depth perception.The corneal haze resulted in a decrease in best corrected distance visual acuity (bcdva) from 20/20 (preoperatively) to 20/25 at onset.At last examination on (b)(6) 2017, corneal haze persisted and bcdva decreased to 20/32.The inlay is scheduled for explantation on (b)(6) 2017.According to the surgeon, the patient's ocular history (dry eye and meibomian gland dysfunction) was a contributing factor.Additional information is being requested.

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.Surface damage 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.Complaint reference number: (b)(4).

Event Description

Rvo received new information indicating that the inlay was explanted on (b)(6) 2017.At last examination one month post-explant, there was some residual (trace) corneal haze and bcdva remained at 20/32.

• 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: 6798670
• MDR Text Key: 82841554
• Report Number: 3005956347-2017-00089
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: G090149
• 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,Followup
• Report Date: 10/12/2017

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: 09/01/2013
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• 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