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 Corneal Clouding/Hazing (1878)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

The device was lost by the user facility and 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.Corneal haze is listed in the device labeling as a known potential risk.Complaint reference #: (b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2016.The inlay was explanted 10 months postoperatively to address 1-2+ corneal haze.At onset, the patient's best corrected distance visual acuity had decreased from 20/20 preoperatively to 20/30-2.Prior to inlay explant, the patient was treated with topical steroids with bcdva improving to 20/25.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon provided the following additional information.There were no complications during surgery to implant the inlay and the patient had no pre-existing conditions.The first onset of corneal haze was on (b)(6) 2017 and the haze persisted until the inlay was explanted.At last examination the patient's bcdva returned to baseline (20/20) and the haze resolved.

• 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: 6950193
• MDR Text Key: 89349042
• Report Number: 3005956347-2017-00121
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/29/2017
• 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
• Patient Age: 48 YR