MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-19 for RAINDROP NEAR VISION INLAY 610-0001 RD1-1 manufactured by Revision Optics.
[97790162]
The inlay remains implanted in the patient at this time and the device will be requested post explant. 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)
Patient Sequence No: 1, Text Type: N, H10
[97790163]
The patient underwent implantation of the raindrop corneal inlay on (b)(6) 2017. Postoperatively, the patient has presented with dense central corneal haze and the inlay is scheduled to be explanted on (b)(6) 2018. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005956347-2018-00015 |
| MDR Report Key | 7206931 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-12-22 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2016-08-22 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PUSHPITA SINGH |
| Manufacturer Street | 25651 ATLANTIC OCEAN DR., STE. A1 |
| Manufacturer City | LAKE FOREST CA 926308835 |
| Manufacturer Country | US |
| Manufacturer Postal | 926308835 |
| Manufacturer Phone | 9497072740 |
| Manufacturer G1 | REVISION OPTICS |
| Manufacturer Street | 25651 ATLANTIC OCEAN DR., STE. A1 |
| Manufacturer City | LAKE FOREST CA 926308835 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 926308835 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAINDROP NEAR VISION INLAY |
| Generic Name | CORNEAL INLAY |
| Product Code | LQE |
| Date Received | 2018-01-19 |
| Model Number | 610-0001 |
| Catalog Number | RD1-1 |
| Lot Number | 002984 |
| Device Expiration Date | 2019-08-22 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS |
| Manufacturer Address | 25651 ATLANTIC OCEAN DR., STE. A1 LAKE FOREST CA 926308835 US 926308835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-19 |