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 Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Loss of Vision (2139); Visual Disturbances (2140)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection.Dimensional analysis (measurement of edge thickness and diameter) was attempted, but was unable to be performed due to the damaged condition of the inlay, where large portions were torn off and missing.Since there was no report of inlay damage, the damage is presumed to have occurred during the explant procedure.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, decreased vision, visual symptoms, and dry eye are listed in the device labeling as known potential risks.(b)(4).

Event Description

The subject was enrolled in the ide clinical trial and underwent uneventful implantation of the investigational corneal inlay in the left eye on (b)(6) 2013.Four months postoperatively, the patient presented with corneal haze in the operative eye.There were numerous recurrences of corneal haze throughout the course of the study and beyond.The haze was characterized as recurrent central haze, grade i.The patient reported experiencing significant visual disturbances (ghosting and foreign body sensation) and dry eye.In addition, best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/40 immediately prior to explantation, which was performed on (b)(6) 2017.At last examination on (b)(6) 2017, haze was improving and bcdva improved to 20/25.

• 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: 6681025
• MDR Text Key: 78897540
• Report Number: 3005956347-2017-00065
• 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: Physician
• Type of Report: Initial
• Report Date: 06/30/2017

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: 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: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/30/2017
• 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: 54 YR