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 Problems Corneal Clouding/Hazing (1878); Loss of Vision (2139)

Event Date 12/07/2017

Event Type  Injury  

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 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
• 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: 7148518
• MDR Text Key: 95847907
• Report Number: 3005956347-2017-00166
• 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: Physician
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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: 62 YR