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

Model Number 600-0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Corneal Clouding/Hazing (1878)

Event Date 07/28/2017

Event Type  Injury  

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 was performed and there were no discrepancies or unusual findings related to the reported issue.Corneal haze is listed in the device labeling as a known potential risk.Complaint reference number: (b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.Four months postoperatively the patient presented with corneal haze in the operative eye.Topical steroids were prescribed, but medication compliance was questionable.On (b)(6) 2017, the inlay was explanted to address persistent corneal haze.Inlay replacement is being considered once the haze resolves.Additional information has been requested.

Manufacturer Narrative

Complaint reference #: (b)(4).

Event Description

The surgeon provided the following new information.Preoperatively, the patient's best corrected distance visual acuity (bcdva) was 20/20 and there was no decrease in bcdva compared to baseline.Corneal haze was first diagnosed on (b)(6) 2017.Immediately prior to explantation of the inlay, the corneal haze was grade 3+.The patient admitted to being non-compliant with the prescribed postoperative steroid medications and the surgeon believes this was a contributing factor.At last examination one month post-explant, the patient's bcdva remained at 20/20 and although the haze decreased to grade 2-3+, it was still significant.

Manufacturer Narrative

(b)(4).

Event Description

The surgeon provided the following update.At last examination on (b)(6) 2017, the patient's bcdva was 20/20.The corneal haze improved to grade 1-2+ and all medications were discontinued; the haze is expected to clear over time.

• 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: 6821256
• MDR Text Key: 83670714
• Report Number: 3005956347-2017-00093
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (y/n): N
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2017

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: 11/22/2019
• Device Model Number: 600-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 003045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 08/28/2017; 10/27/2017
• Supplement Dates FDA Received: 09/27/2017; 10/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR