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

Model Number 610-0001

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

Patient Problems Herpes (1898); Inflammation (1932)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

The corneal inlay was not 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 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 in the left eye on (b)(6) 2017.Two months postoperatively, the patient was treated with topical steroids for inflammation inferior to the inlay.Four months postoperatively the patient was diagnosed with (b)(6) in the operative eye and steroids and antiviral medications were prescribed.One week later the surgeon was unable to visualize the inlay under the lasik flap; intervention was required to amputate the flap on (b)(6) 2017.Additional information has been 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: 7204590
• MDR Text Key: 97714914
• Report Number: 3005956347-2018-00014
• 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: 01/18/2018

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: 11/08/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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): Disability
• Patient Age: 54 YR