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 Problems Corneal Clouding/Hazing (1878); Intraocular Pressure Increased (1937); Loss of Vision (2139)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

The device was not available for evaluation.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Increased intraocular pressure, corneal haze, and decreased vision are listed in the device labeling as known potential risks.Complaint reference #: (b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2016.On (b)(6) 2017, the patient presented with 1+ corneal haze near the edge of the inlay.The patient's best corrected distance visual acuity (bcdva) decreased from 20/16 (preoperatively) to 20/32-1 at onset and the patient complained of ghost images sometimes affecting night driving.On (b)(6) 2017, the patient had a steroid response with intraocular pressure (iop) increasing from 22 mmhg (preoperatively) to 42 mmhg and the inlay was explanted on (b)(6) 2017.One week post explant, the patient's bcdva improved to 20/25 and residual haze was observed in the area where the inlay was.

• 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: 6863274
• MDR Text Key: 86079716
• Report Number: 3005956347-2017-00103
• 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: 09/13/2017

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: 08/22/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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