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); Blurred Vision (2137); Loss of Vision (2139); Visual Disturbances (2140)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested to confirm that the device was explanted as planned and request that it be returned for evaluation.The device history record (dhr) 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.Complaint reference number: (b)(4).

Event Description

The subject was enrolled in the (b)(6) clinical trial and underwent implantation of the investigational corneal inlay in the left eye on (b)(6) 2013.Four years postoperatively, the patient presented with corneal haze and complained of poor near vision and headaches from eye strain.The patient was prescribed topical steroids, but requested inlay explantation (scheduled for (b)(6) 2017).Additional information has been 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.Scratches and debris 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.Decreased bcdva and visual symptoms are listed in the device labeling as known potential risks.(b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.Corneal haze is characterized as grade 1, central.The patient's best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/25 at onset of issue.Corneal haze resulted in visual disturbances such as blurred vision, ghost images, double vision and fluctuation of vision which caused frequent headaches to the patient.Headache is described as mild to moderate when trying to focus at near.The inlay was explanted on (b)(6) 2017.Non-compliance with the prescribed steroid regimen is suspected to be contributory to the reported issues.

Manufacturer Narrative

Complaint reference #: (b)(4).

Event Description

The investigator provided the following update on the study subject.At the one-month post-explant examination on (b)(6) 2017, bcdva was 20/25 and the patient reported experiencing moderate pain and aching.

• 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: 6745513
• MDR Text Key: 81112500
• Report Number: 3005956347-2017-00075
• 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,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2012
• 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
• Patient Age: 50 YR