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 Corneal Clouding/Hazing (1878); Loss of Vision (2139)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer; however, thorough microscopic inspection revealed there was no inlay inside the lens case and no analysis could be performed.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 and vision decrease are listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent uneventful implantation of the corneal inlay in the left eye on (b)(6) 2017.Two weeks postoperatively, the patient presented with minimal corneal haze at which time best corrected distance vision (bcdva) decreased from 20/20 (preoperatively) to 20/30.The patient was treated with topical steroids, but when the steroids were discontinued mild haze recurred.The patient's bcdva decreased to 20/80 before the inlay was explanted on (b)(6) 2017.At last examination several days post explant, bcdva improved to 20/50 and the corneal haze resolved.

• 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: 7088101
• MDR Text Key: 93888239
• Report Number: 3005956347-2017-00150
• 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: 12/06/2017

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: 08/01/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: 47 YR