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

Model Number 610-001

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Corneal Edema (1791); Loss of Vision (2139); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

The explanted inlay was discarded by the facility and is not available for evaluation.The device history record (dhr) review of the manufacturing lot for this device was performed and there were no discrepancies or unusual findings related to the reported issue.Inlay shifts in position and inlay removal are listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.Several hours after the procedure the patient returned to the facility and the inlay was noted to be decentered > 1 mm inferiorly; the inlay was repositioned.At the one-day postoperative visit, the inlay had decentered again (> 1 mm) and was explanted.A new inlay will be implanted at a later date.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Patient follow-up was requested from the surgeon, who provided the following additional information.The corneal inlay surgery was uneventful.Inlay decentered 3-4 mm inferior nasally.Prior to explantation of the corneal inlay, the patient's best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/60 immediately prior to explantation.Corneal edema is suspected to be contributory to cause inlay decentration.Approximately 1-month post explantation, the bcdva returned to baseline and the patient condition was stable and prognosis was good.

• 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: 6577346
• MDR Text Key: 75523048
• Report Number: 3005956347-2017-00044
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)191202(10)003050
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/02/2019
• Device Model Number: 610-001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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 Age: 65 YR