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

Model Number 610-0001

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Corneal Abrasion (1789); Corneal Edema (1791); Visual Impairment (2138); Loss of Vision (2139)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

This mdr is being filed for the first corneal inlay device that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.Reference mdr # 3005956347-2016-00009 for the second inlay device that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.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 explanted inlay was not returned to the manufacturer so physical product investigation could not be performed.(b)(4).Date emdr submitted to fda: 12/09/2016.

Event Description

During the surgery to implant the raindrop corneal inlay, the corneal flap folded during the attempt to close the flap.The patient had edema after the surgery.At the one-day postoperatively examination, the raindrop corneal inlay was found to be decentered inferiorly.The flap was lifted and the inlay was removed and replaced with a new inlay.Four days later, the inlay was found to be decentered again and it was removed and replaced with a new inlay.Additional information has been requested.

Manufacturer Narrative

[correction] the raindrop inlay (serial number: (b)(4)) was implanted and removed the same say as it was moving around and corneal flap was not holding the inlay in place.This smdr is being filed for the 1st corneal inlay device that was implanted on (b)(6) 2016 and explanted the same day.Reference mdr # 3005956347-2016-00009 for the 2nd raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.Reference mdr # 3005956347-2017-00011 for the 3rd raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.Reference mdr # 3005956347-2017-00012 for the 4th raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.Complaint reference number: (b)(4).Date esmdr submitted to fda: 01/18/2017.

Event Description

A raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016 and removed the same day as the inlay was moving around.After this implantation, three raindrop inlays have been implanted and removed due to inlay decentration and corneal flap not holding inlay in place.The third inlay was implanted on (b)(6) 2016 and replaced with a new raindrop inlay on (b)(6) 2016.The fourth inlay was found to be decentered at the one-day postoperative visit and subsequently explanted on (b)(6) 2016.The patient's preoperative best corrected distance visual acuity (bcdva) in the operative eye was 20/20.Prior to intervention, bcdva decreased to 20/300.After intervention, the patient's bcdva improved to 20/30.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.The patient was last examined on (b)(6) 2017.During this exam, the patient complained of decreased distance vision in comparison to preoperative distance vision.The patient's best corrected distance visual acuity (bcdva) has returned to baseline (20/20).Trace epithelial ingrowth was observed, cornea was clear with minimal debris but no haze.Corneal topography showed irregular astigmatism which was not a preexisting condition for this patient.The patient was recommended to use artificial tears a couple of times a day.

• 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: 6160389
• MDR Text Key: 62084072
• Report Number: 3005956347-2016-00008
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190822(10)002984
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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: 51 YR