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 08/28/2017

Event Type  Injury  

Manufacturer Narrative

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 implantation of the corneal inlay in the left eye on (b)(6) 2016.The study allows concurrent lasik and includes the use of low-dose mitomycin c on the exposed stromal bed immediately prior to inlay implantation.The subject presented with central corneal haze in the operative eye 14 months postoperatively.The inlay was explanted on (b)(6) 2017 to address grade 0.5 central corneal haze.Preoperatively, the patient's best corrected distance visual acuity (bcdva) was 20/20, but bcdva was not measured at onset of corneal haze or prior to explant.The surgeon believes that extended debris in the femtosecond laser corneal flap was a contributing factor.

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.(b)(4).

Event Description

Rvo received the following updated information.At last examination on (b)(6) 2017, the corneal haze has resolved.

Manufacturer Narrative

Complaint reference #: (b)(4).

Event Description

The patient had concurrent lasik performed in the operative eye at the time of inlay implantation.

• 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: 6898011
• MDR Text Key: 87525482
• Report Number: 3005956347-2017-00111
• 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,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: 07/08/2017
• 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: 08/28/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/27/2017; 11/08/2017
• Supplement Dates FDA Received: 10/24/2017; 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
• Treatment: MITOMYCIN-C, FEMTOSECOND LASER FOR FLAP CREATION
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR