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 Corneal Edema (1791); Corneal Clouding/Hazing (1878); Blurred Vision (2137); Loss of Vision (2139)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) for this manufacturing lot was reviewed and the device met all release criteria and there were no discrepancies or unusual findings that relate to the reported event.The device is still implanted in the patient's eye and not available for evaluation.Patient is a heavy smoker which could be a contributing factor.Corneal haze and decreased vision are listed in the device labeling as known complications of corneal inlay surgery.(b)(4).

Event Description

The subject was enrolled in the clinical study for (b)(4) and underwent surgery on (b)(6) 2011 with implantation of the investigational corneal inlay.The patient was lost for follow-up after (b)(6) 2012 visit until (b)(6) 2016.During this time, he was not under the care of an ophthalmologist.At (b)(6) 2016 visit, patient presented with corneal haze in the operative eye with decreased best corrected distance visual acuity (bcdva) at 20/30 (baseline was 20/20).At 1 month follow-up visit after starting the steroid treatment, peripheral edge haze persisted and bcdva remained unchanged at 20/30.Myopic shift and corneal edema was also noticed.Patient elected inlay explantation instead of further steroid treatment.Inlay explantation is scheduled for (b)(6) 2017.

Manufacturer Narrative

(b)(4).

Event Description

Patient status was requested and the following update was received.Post-explant, the patient was prescribed steroids (loteprednol), but the patient reported that he ran out of the medication and did not inform the clinic.On (b)(6) 2017 (1-month post-explant follow-up visit), the patient's bcdva was 20/40+.The patient was directed to continue with steroids (difluprednate).On (b)(6) 2017 (2-month post explant follow-up visit), the patient's bcdva remained unchanged at 20/40+.There was mild-to moderate corneal haze observed around the inlay site.Haze was resolving.The patient was instructed to return on (b)(6) 2017 but did not return.The patient is presumed to have been lost for follow-up.

• 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: 6224099
• MDR Text Key: 63911425
• Report Number: 3005956347-2017-00001
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 08/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Model Number: PP6-530-0027-US
• Device Lot Number: 002033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2012
• 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
• Treatment: ARTIFICIAL TEARS; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP; VISINE
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR