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); Inflammation (1932); Loss of Vision (2139); Visual Disturbances (2140); Halo (2227)

Event Date 10/13/2017

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

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.Corneal haze, halos, and glare are listed in the device labeling as known potential risks.Additional information: complaint reference number: (b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.The procedure to implant the corneal inlay in the patient's left eye was uneventful.Corneal haze was first observed at the one-month postoperative visit with recurrences of mild haze at 4 and 5 months postoperatively.Prior to explantation of the corneal inlay, the corneal haze progressed to grade 3+, located in the area of the inlay.The corneal haze was associated with significant halos and glare that impacted the patient's ability to drive.In addition, the patient's best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/50 (immediately prior to inlay explantation).Post inlay explant, the corneal haze and halo/glare symptoms resolved and bcdva improved to 20/25-2.

• 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: 7019045
• MDR Text Key: 91765589
• Report Number: 3005956347-2017-00138
• 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,Followup
• Report Date: 12/27/2017

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: 10/21/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003007
• 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
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• 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
• Patient Age: 59 YR