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

Model Number 610-0001

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

Patient Problem Inflammation (1932)

Event Date 09/30/2017

Event Type  Injury  

Manufacturer Narrative

Device identifiers have been requested.Corneal inflammation is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay on (b)(6) 2016.The inlay was explanted sometime in (b)(6) 2017 (exact date unknown) due to corneal inflammation.The seriousness of the inflammation and impact on vision are not known at this time.Additional information has been requested.

• 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: 7019008
• MDR Text Key: 91771926
• Report Number: 3005956347-2017-00137
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150034
• 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
• Report Date: 11/10/2017

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 Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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