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

Model Number 610-0001

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

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Visual Impairment (2138)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and evaluated and subjected to visual microscopic inspection.The findings revealed that a portion of the inlay edge was torn off and some debris was observed on the inlay, presumably the sebaceous debris as reported by the customer.The torn condition of the inlay is consistent with findings for inlays that have been explanted.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.It is unknown if the first inlay potentially contributed to the events following implantation of the replacement corneal inlay, therefore an mdr is being filed for both devices.Corneal edema, decreased visual acuity, inlay shifts in position, intraocular pressure rise, and inlay removal are listed in the device labeling as known complications of corneal inlay surgery.Complaint reference number: (b)(4).Reference mdr #3005956347-2016-00004 (for the replacement corneal inlay).Date emdr submitted to fda: 11/9/2016.

Event Description

Corneal inlay implantation was performed on (b)(6) 2016 on the patient's right eye.At the one-day postoperative visit, the patient presented with some sebaceous interface debris.At the one-week postoperative visit on (b)(6) 2016, debris was graded as 1+ and the patient's best corrected distance visual acuity (bcdva) remained unchanged at 20/20 (compared to the baseline).At this visit the corneal flap was irrigated, which required replacement of the corneal inlay.There was no reported problem with the initial or replacement inlay.Patient follow-up information was received on october 11, 2016, indicating that on (b)(6) 2016 the patient had presented with corneal edema, an inferior shift in inlay position, elevated iop (40 mmhg), and a significant decrease in bcdva (20/150 as compared to 20/20 at baseline).At this visit, the replacement inlay was explanted and no new inlay was implanted.Additional information has been requested.

Manufacturer Narrative

The patient's increased iop from the steroid response was suspected as triggering the reported event.(b)(4).Reference mdr #3005956347-2016-00004 (for the replacement corneal inlay).Date esmdr submitted: 12/29/2016.

Event Description

The surgeon provided the following additional information.The patient's preoperative intraocular pressure (iop) was 16 mmhg.The patient was a steroid responder and the increased pressure to 40 mmhg (as reported in the initial report) caused corneal edema, which caused the inlay to shift position.The patient's current best corrected distance visual acuity (bcdva) improved from 20/150 to 20/20 and iop decreased to 22 mmhg.

• 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: 6094025
• MDR Text Key: 59717273
• Report Number: 3005956347-2016-00005
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190801(10)002968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

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: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR