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

Model Number PP3-530-0027-US

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

Patient Problems Corneal Edema (1791); Corneal Clouding/Hazing (1878)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

The explanted corneal inlay has not been returned to the manufacturer at this time.The site is being contacted to determine whether it is still 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 haze and corneal swelling are listed in the device labeling as a known potential risk.(b)(4).

Event Description

The subject was enrolled in a foreign clinical trial and underwent implantation of the investigational raindrop corneal inlay in the left eye on (b)(6) 2009.The inlay was explanted 8+ years postoperatively to address persistent central corneal haze with first known onset at month 82.The haze was graded as 0.5 immediately prior to explant.Oct performed at month 99 showed mild corneal edema and haze with 1.0 d flattening and a 0.625 d hyperopic shift.The patient's bcdva at month 99 was 20/20.It should be noted that the subject had not been examined since 2009.Additional information is being requested.

• 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: 7136654
• MDR Text Key: 95450128
• Report Number: 3005956347-2017-00163
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/01/2009
• Device Model Number: PP3-530-0027-US
• Device Lot Number: 0020898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2009
• 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