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); Tissue Damage (2104)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The edge thickness and diameter were measured and found to be within specifications.Damage (cuts and small tear) and debris were observed on the device, but these findings are consistent with findings for corneal inlays that have been explanted since surgical instruments are required to remove the device from the eye and place it in a hydrated storage container for transport.The device history record (dhr) 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 number: (b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2016.On (b)(6) 2017 the patient presented with corneal haze.The inlay was explanted 8 months postoperatively due to persistent corneal haze.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon examined the patient 6 weeks post inlay removal and reports the patient is improving with a best corrected visual acuity of 20/25-.

Manufacturer Narrative

Corneal melting is listed in the device labeling as a known risk.Complaint reference #: (b)(4).

Event Description

The surgeon provided the following event details and update.The patient first presented with corneal haze on (b)(6) 2017, which recurred on (b)(6) 2017 and progressed to severe central corneal haze that resulted in a corneal melt on (b)(6) 2017.The patient's preoperative bcdva was 20/20, decreasing to 20/25-2 at onset of haze and immediately prior to explantation of the inlay.At last examination 3 months post explant, bcdva was 20/25 and the surgeon reports the patient is very slowly improving.

• 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: 6745675
• MDR Text Key: 81112062
• Report Number: 3005956347-2017-00076
• 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,Followup,Followup
• Report Date: 10/30/2017

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: 08/08/2019
• Device Model Number: 600-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 08/10/2017; 10/30/2017
• Supplement Dates FDA Received: 09/08/2017; 10/30/2017
• 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; Disability
• Patient Age: 48 YR