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

Model Number	600-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Clouding/Hazing (1878); Loss of Vision (2139)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted inlay was returned to the manufacturer, and the investigation is underway.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 and decreased vision are listed in the device labeling as known potential risks.(b)(4).
Event or Problem Description
The patient underwent uneventful implantation of the raindrop corneal inlay in the left eye on (b)(6) 2016.The patient presented with corneal haze and decreased visual acuity on (b)(6) 2017.The corneal haze persisted despite compliant treatment with topical steroids.At examination on (b)(6) 2017, the haze worsened to grade 2-3+ (central).The patient's best corrected distance visual acuity (bcdva) decreased from 20/20 (preoperatively) to 20/30-2 at onset, and 20/30 immediately prior to intervention.The patient did not respond to steroids and on (b)(6) 2017 the inlay was removed and replaced with a new inlay and mitomycin-c was administered in the flap interface.At last examination one week post inlay exchange, bcdva was 20/50 and the corneal haze improved to mild.According to the surgeon, presence of the inlay contributed to the event.

• 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: 7148518
• Report Number: 3005956347-2017-00166
• Device Sequence Number: 1736939
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P150034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/01/2019
• Device Model Number: 600-0001
• Device Catalogue Number: RD1-1
• Device Lot Number: 002968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/27/2017
• 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
• Patient Age: 62 YR