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

Model Number 606-0001

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

Patient Problems Corneal Clouding/Hazing (1878); Visual Disturbances (2140); Halo (2227)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

The site is being contacted to clarify whether the device is available for evaluation.The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Corneal haze, halos, and double vision are listed in the device labeling as known potential risks.(b)(4).

Event Description

The subject was enrolled in a foreign clinical trial and underwent uneventful implantation of the investigational raindrop corneal inlay in the right eye on (b)(6) 2017.The inlay was explanted 5 weeks postoperatively to address faint central corneal haze.The patient also reported experiencing moderate halos and marked double vision.The surgeon believes that extended debris in the flap interface contributed to the development of haze.The haze did not result in a clinically significant decrease in best corrected distance visual acuity (bcdva).The patient is scheduled for examination 1-month and 3-months post inlay removal.

Manufacturer Narrative

The explanted device was returned to the manufacturer; however, thorough microscopic inspection revealed there was no inlay inside the container and no further analysis could be performed.(b)(4).

Event Description

Patient follow-up was requested from the study personnel, who provided the following additional information.At last examination on (b)(6) 2017, the visual disturbances (halos/double vision) had resolved and bcdva returned to baseline (20/16) with persistent trace central corneal haze.Additional information has been requested.

• 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: 6967252
• MDR Text Key: 89912817
• Report Number: 3005956347-2017-00128
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

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: 04/19/2019
• Device Model Number: 606-0001
• Device Lot Number: 003080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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: 46 YR