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 09/15/2017

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 left eye on (b)(6) 2016.The study involved the use of a corneal pocket for implantation of the inlay.One year postoperatively the patient presented with faint central corneal haze and the inlay was explanted on (b)(6) 2017.The surgeon believes that extended debris in the corneal pocket contributed to the development of haze.The haze did not result in a 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 device history record 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

Additional information was requested from study personnel, who provided the following additional information.The patient was examined one month post explant on (b)(6) 2017.At this visit the patient's best corrected distance visual acuity (bcdva) remained stable at 20/16 with persistent trace (0.5) central corneal haze.

• 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: 6963035
• MDR Text Key: 89807200
• Report Number: 3005956347-2017-00125
• 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: 01/10/2018

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
• 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: 12/14/2017
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 56 YR