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

Model Number 600-0032

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

Patient Problems Corneal Edema (1791); Corneal Clouding/Hazing (1878)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

The explanted corneal inlay has not been returned to the manufacturer at this time.The site is being contacted to determine whether it is still available for analysis.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.Corneal haze and corneal swelling are listed in the device labeling as known potential risks.(b)(4).

Event Description

The subject was enrolled in a foreign clinical trial and underwent implantation of the investigational raindrop corneal inlay in the right eye on (b)(6) 2015.The study involved placement of the inlay inside a corneal pocket in emmetropic subjects.The inlay was explanted 2 years postoperatively to address persistent central corneal haze with first onset at month 12.The haze was graded as trace/1 immediately prior to explant.Oct performed at month 24 showed corneal edema and haze with slight flattening and a 0.87 d hyperopic shift.Additional information is being requested.

• 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: 7136207
• MDR Text Key: 95450124
• Report Number: 3005956347-2017-00162
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/01/2017
• Device Model Number: 600-0032
• Device Lot Number: 002593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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