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

Model Number PP6-530-0027

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

Patient Problems Corneal Scar (1793); Inflammation (1932); Tissue Damage (2104); Loss of Vision (2139); Visual Disturbances (2140)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

The corneal inlay had extruded through the flap and was not available for analysis.The device history record review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal melting, corneal scarring, corneal inflammation, loss of vision, and increased visual symptoms are listed in the device labeling as known potential risks.Complaint reference number: (b)(4).

Event Description

The subject was enrolled in the u.S.Ide clinical trial and underwent implantation of the investigational raindrop corneal inlay in the left eye on (b)(6) 2013.Four years postoperatively the subject was diagnosed by an ophthalmologist (not the study investigator) with (b)(6) over the inlay and was prescribed steroids and antiviral medications for 2 weeks with no resolution.The patient was later seen by the ide investigator who did not confirm the diagnosis of (b)(6), but instead reported focal dense central scarring anterior and posterior to the inlay with melting of the stroma and disruption of the epithelium directly over the inlay with very poor vision.The patient was prescribed steroids and the inlay was scheduled to be explanted.During the intervention, the inlay was not removed because it had extruded through the flap.Additional information is being requested.In addition to the report from the study investigator, the study subject also contacted the manufacturer and reported experiencing ocular irritation, sensitivity to light, and eye tearing.The patient denies having a medical history of (b)(6), but disclosed he has allergies and admitted to eye rubbing.

• 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: 7181212
• MDR Text Key: 96934169
• Report Number: 3005956347-2018-00011
• 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: 01/10/2018

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: 07/01/2013
• Device Model Number: PP6-530-0027
• Device Lot Number: 002354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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): Disability
• Patient Age: 58 YR