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

Model Number	610-0001
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Retinal Detachment (2047)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted inlay was discarded by the facility and is not available for evaluation.The device history record review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Retinal detachment and inlay shifts in position are listed in the device labeling as known potential risks.It should be noted that the device labeling includes the following precaution: "removal of the inlay may be necessary prior to any retinal or vitreal procedures or prior to laser procedures due to potential difficulty with viewing and/or delivering the appropriate laser energy or other treatment to the desired target tissue on through the raindrop near vision inlay.In addition, with the exception of nd-yag bench testing on the inlay, the safety of laser procedures or other treatments involving delivery of energy through the inlay have not been investigated." complaint reference number: (b)(4).
Event or Problem Description
The patient underwent implantation of the corneal inlay in the left eye on (b)(6) 2017.One month postoperatively, the patient had a retinal detachment that required surgical intervention.At the postoperative examination following the retinal repair, the inlay was noted to be decentered inferiorly; on (b)(6) 2017, the inlay was subsequently explanted.Additional information is being requested.

• Brand Name: RAINDROP NEAR VISION INLAY
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest CA 92630 8835
• MDR Report Key: 7162901
• Report Number: 3005956347-2018-00003
• Device Sequence Number: 19298559
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/05/2020
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention