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

Model Number 610-0001

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Vision (2139)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

The inlay remains implanted and is; therefore, not available for evaluation.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Decreased best corrected distance visual acuity is listed in the device labeling as a known potential risk.(b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017.Postoperatively, the patient's best corrected distance visual acuity (bcdva) decreased 2 or more lines compared to baseline.The postoperative bcdva was not provided, and the inlay remains implanted.The patient had concurrent lasik at the time of inlay implantation, and the ocular history includes superficial punctate keratopathy (spk) and dry eye.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

At last examination of (b)(6) 2017, the patient's best corrected distance visual acuty (bcdva) was 20/40.Additional information has been requested.

Manufacturer Narrative

The explanted inlay was returned to the manufacturer and subjected to visual microscopic inspection and dimensional analysis.The edge thickness and diameter were measured and found to be within specifications.The inlay was received in a dehydrated state with a small portion of the inlay torn-off near the edge and small cuts and particles on the device.These findings are consistent with findings for corneal inlays that have been explanted since surgical instruments are required to remove the device from the eye and place it in a storage container for transport.It should be noted that the device was not properly stored during transport and it was received in a non-hydrated state.(b)(4).

Event Description

At the 8-month postoperative visit on (b)(6) 2017, the patient's bcdva had improved to 20/25-2; however, examination revealed that the inlay had decentered inferior-nasally.The inlay was subsequently explanted on (b)(6) 2017.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; 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: 6959912
• MDR Text Key: 89689788
• Report Number: 3005956347-2017-00122
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• 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: Medical Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

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?: No
• Device Operator: Physician
• Device Expiration Date: 11/08/2019
• Device Model Number: 610-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/23/2017; 11/27/2017
• Supplement Dates FDA Received: 11/21/2017; 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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
• Patient Age: 55 YR