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

Model Number 600-0001

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

Patient Problems Corneal Clouding/Hazing (1878); Visual Disturbances (2140)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was discarded by the facility and is not available for evaluation.The device history record review o f the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal haze is listed in the device labeling as a known potential risk.Complaint reference number: (b)(4).

Event Description

On (b)(6) 2017 the patient underwent implantation of the raindrop corneal inlay with use of on (b)(6) 2017.Postoperatively, the patient presented with corneal haze, and the inlay was subsequently exchanged on (b)(6) 2017.Additional information has been requested.

Manufacturer Narrative

Double vision is listed in the device labeling as a known potential risk.It should be noted that this mdr event appears to be the same patient filed under mfr# 3005956347-2017-00148, but without confirmation of the device identifiers we are unable to confirm.Complaint reference number: (b)(4).

Event Description

The following additional information was provided by the surgeon, who reports performing concurrent lasik with uneventful implantation of the inlay in the patient's right eye.The patient first presented with trace corneal haze inferior to the inlay on (b)(6) 2017.Seven months postoperatively the patient reported experiencing double vision, but there was no significant decrease in bcdva.At last examination post inlay exchange on (b)(6) 2017, the corneal haze resolved, however the patient reports that the letters on the eye chart appear distorted.

• 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: 7073203
• MDR Text Key: 93420898
• Report Number: 3005956347-2017-00147
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/16/2019
• Device Model Number: 600-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2016
• 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: 55 YR