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

Model Number PP6-530-0027-US

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

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The findings revealed that the inlay was received folded and damaged with large sections of the inlay torn off and the presence of several cuts and particles.The edge thickness was measured and found to be within specifications; however, the damaged condition of the inlay precluded measurement of the diameter.The damaged condition of the inlay is suspected as being caused by removal from the eye, excessive handling, and improper storage during transport.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 is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The subject was enrolled in the (b)(6) clinical trial and underwent implantation of the investigational corneal inlay in the left eye on (b)(6) 2013.At the 48-month exam on (b)(6) 2017, the subject presented with grade 3 central corneal haze and durezol was prescribed.The subject was examined two weeks later and the slit lamp examination showed no improvement in haze; the inlay was explanted on (b)(6) 2017.The corneal haze did not result in a significant decrease in best corrected distance visual acuity.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested, and the following additional information was received.At last examination on (b)(6) 2017, the corneal haze reduced to grade 1, and the bcdva was 20/25 (44 letters).

• 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: 6862835
• MDR Text Key: 86076670
• Report Number: 3005956347-2017-00101
• 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: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

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: 05/31/2014
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 12/14/2017
• 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: 53 YR