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

Model Number 610-0001

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Corneal Scar (1793); Corneal Clouding/Hazing (1878); Keratitis (1944); Visual Impairment (2138); Burning Sensation (2146)

Event Date 10/28/2016

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.Inlay decentration is listed in the device labeling as a known complication of corneal inlay surgery.Dlk is also listed in the device labeling and is commonly associated with corneal flap procedures.The instructions for use for the raindrop near vision inlay specifies that the corneal flap must be a minimum of 150 microns thick; however, the patient's flap was only 120 microns.The flap thickness and off-label use of celluvisc may have been contributory to the reported issues.(b)(4).Date emdr submitted to fda: 12/15/2016.

Event Description

Corneal inlay implantation was performed on (b)(6) 2016 on the patient's left eye.During corneal flap creation using a femtosecond laser, the patient inadvertently received a flap thickness of 120 microns even though the surgeon ordered 180 microns.At the end of the procedure, several drops of celluvisc were instilled on the flap.At the one-day postoperative visit, the patient complained of blurry vision and stinging sensation.The inlay had decentered slightly inferiorly and the patient was diagnosed with trace diffuse lamellar keratitis (dlk).The postoperative steroid regimen included durezol and vigamox and artificial tears as needed.The patient's preoperative best corrected distance visual acuity (bcdva) was 20/20.New information was received on (b)(6) 2015 indicating that the inlay will be explanted due to decentration.Additional information was requested and on (b)(6) 2016 the surgeon provided the following update.At onset, the patient's postoperative bcdva decreased to 20/50, but improved to 20/15 on (b)(6) 2016.On (b)(6) 2016, the flap was irrigated and the inlay was removed and replaced with a new inlay in order to address both dlk and inlay decentering, which was described as slightly inferior.The dlk resolved.

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection.The findings revealed that the inlay was folded and dehydrated.As a result, no dimensional measurements could be performed.Complaint (b)(4).Date esmdr submitted: 03/02/2017, reference mdr# 3005956347-2017-00004 for the replacement inlay.

Event Description

An adverse event occurred with the replacement raindrop corneal inlay that was implanted in the patient's left eye on (b)(6) 2016.Reference mdr# 3005956347-2017-00004 which was filed for the replacement inlay for this same patient.

Manufacturer Narrative

(b)(4).Reference mdr# 3005956347-2017-00004 for the events involving the second inlay.

Event Description

The following new information was provided on july 26, 2017.At last examination on (b)(6) 2017, the patient's bcdva improved to 20/20 with trace central corneal haze and minimal epithelial in-growth.There is no further patient follow-up scheduled.

• 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: 6179681
• MDR Text Key: 62525316
• Report Number: 3005956347-2016-00010
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190808(10)002979
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002979
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005956347-02/03/17-001
• Patient Sequence Number: 1
• Treatment: CELLUVISC ARTIFICIAL TEARS; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR