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 2018-01-17 for RAINDROP NEAR VISION INLAY 610-0001 RD1-1 manufactured by Revision Optics.
[97900208]
The inlay remains implanted in the patient 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 is listed in the device labeling as a known potential risk. Reference mfr report # 3005956347-2017-00117 for the initial inlay serial# 002979-337; and mfr report #3005956347-2017-00118 for the replacement inlay serial # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97900209]
A replacement raindrop corneal inlay was implanted in the patient's left eye on (b)(6) 2017; the procedure was uneventful and proper inlay centration was verified. At some point during the first postoperative week, the inlay decentered 0. 75 mm inferiorly. On (b)(6) 2017, bcdva was 20/25, which was a significant improvement compared to the prior measurement of 20/60. The inlay remains implanted at this time. At last examination, the patient presented with dry eye and mild blepharitis, but the surgeon anticipates a good outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005956347-2018-00012 |
| MDR Report Key | 7202632 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-17 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2017-12-20 |
| Device Manufacturer Date | 2017-06-28 |
| Date Added to Maude | 2018-01-17 |
| 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 | 2018-01-17 |
| 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 | 2018-01-17 |