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); High Blood Pressure/ Hypertension (1908); Loss of Vision (2139)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer; however, there was no inlay found inside the container and no further 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 decreased vision are listed in the device labeling as known potential risks.Hypertension is a potential side effect of topical steroids (e.G., durezol), which are used to treat corneal haze.(b)(4).

Event Description

The patient underwent implantation of the corneal inlay in the right eye on (b)(6) 2016.On (b)(6) 2016, corneal haze was first observed on the edge of the inlay.On (b)(6) 2017, the patient presented with grade 3 recurrent central corneal haze and the inlay was explanted on (b)(6) 2017.The haze was associated with a decrease in best corrected distance visual acuity (bcdva) from 20/20 (preoperatively) to 20/30 at onset, improving to 20/25 immediately prior to explant.One day post explant the corneal haze was resolving.The patient reported experiencing elevated blood pressure during the last 2 weeks of (b)(6).Additional information is being 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: 6801884
• MDR Text Key: 82955383
• Report Number: 3005956347-2017-00090
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/08/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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): Required Intervention
• Patient Age: 60 YR