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

Model Number 610-0001

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/30/2016

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 explanted inlay is discarded by the facility and is not available for evaluation.This mdr is being filed for the 3rd corneal inlay device that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.Reference mdr # 3005956347-2016-00008 for the 1st raindrop corneal inlay 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 # 3005956347-2017-00012 for the 4th raindrop corneal inlay that was implanted on (b)(6) 2016 and explanted on (b)(6) 2016.(b)(4).

Event Description

A raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2016.Prior to this implantation, two raindrop inlays were implanted and removed due to inlay decentration.On (b)(6) 2016, this third inlay was removed and replaced with a new raindrop corneal inlay due to the corneal flap not holding the inlay in place.The fourth inlay was later found to be decentered at the one-day postoperative visit and was 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: 6262610
• MDR Text Key: 65204555
• Report Number: 3005956347-2017-00011
• 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
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• 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?: Device Not Returned to Manufacturer
• 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