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

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

The device history records were reviewed and there were no discrepancies or unusual findings that relate to the reported event.Corneal haze and decreased vision are is listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent uneventful implantation of the investigational raindrop corneal inlay in the left eye on (b)(6) 2012.Inlay explantation was scheduled 5 years postoperatively due to recurrent corneal haze with initial onset at month 18 and recurrences at months 30, 36, and 60.Immediately prior to explant the corneal haze was characterized as grade 1 central haze.The patient's best corrected distance visual acuity (bcdva) decreased from 20/20 preoperatively to 20/32 immediately prior to explant.Additional information is being 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: 7022912
• MDR Text Key: 91890550
• Report Number: 3005956347-2017-00139
• 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: 11/10/2017

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: 06/01/2013
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002345
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2012
• 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): Required Intervention
• Patient Age: 57 YR