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 2018-01-24 for RAINDROP NEAR VISION INLAY 610-0001 RD1-1 manufactured by Revision Optics.
[98164059]
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. Inlay shifts in position, corneal inflammation, and epithelial ingrowth are listed in the device labeling as known potential risks. Complaint reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98164060]
The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2017. Within the first 2 postoperative weeks the patient presented with inferior inlay decentration and inlay repositioning was planned. During this procedure inflammation was observed in the interface in the area of the inlay, likely due to a corneal abrasion a few days prior. In addition, epithelial ingrowth was observed near the corneal flap hinge. On (b)(6) 2017, the inlay was explanted and a replacement inlay will be implanted once the inflammation resolves and the eye is stable. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005956347-2018-00017 |
| MDR Report Key | 7217652 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-24 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2017-12-27 |
| Device Manufacturer Date | 2017-06-28 |
| Date Added to Maude | 2018-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | 2018-01-24 |
| Model Number | 610-0001 |
| Catalog Number | RD1-1 |
| Lot Number | 003166 |
| 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. Life Threatening; 2. Required No Informationntervention | 2018-01-24 |