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

Model Number PP6-530-0027-US

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

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

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The damage observed on the inlay is consistent with findings for corneal inlays that have been explanted.The edge thickness and diameter were measured and found to be within specifications.The device history record (dhr) review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal haze and inlay removal are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).

Event Description

The subject was enrolled in the clinical study for ide #(b)(6) and underwent surgery with implantation of the investigational corneal inlay.Postoperatively, the patient presented with recurrent corneal haze and the inlay was subsequently explanted.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was requested from the study investigator, who provided the following additional event details.The subject underwent inlay implantation in the right eye on (b)(6) 2013.During surgery, the targeted flap depth was 170 microns, however, the actual flap depth was only 149 microns.There were numerous recurrences of corneal haze throughout the course of the study and beyond.The haze was characterized as trace peripheral edge haze and i+ central haze.The patient's best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/40 at onset and 20/32 immediately prior to explantation of the inlay on (b)(6) 2016.At last examination on (b)(6) 2017, bcdva had improved to 20/25 and the patient is doing well and corneal haze improved to trace.

• 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: 6603337
• MDR Text Key: 76375477
• Report Number: 3005956347-2017-00047
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: G090149
• 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: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2014
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2013
• 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: 63 YR