MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for RAINDROP NEAR VISION INLAY manufactured by Revision Optics, Inc..
[128746914]
I had the raindrop near vision inlay procedure. Immediately after the procedure and ever since, i have reported to my eye dr that the inlay did not work, did not help with my near vision and caused blurriness and glare. I was told it takes a long time for this to go away. It has never gone away and my vision is worse with the inlay than before i had the procedure done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081663 |
| MDR Report Key | 8110851 |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-26 |
| Date of Event | 2017-09-07 |
| Date Added to Maude | 2018-11-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RAINDROP NEAR VISION INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRACTIVE |
| Product Code | LQE |
| Date Received | 2018-11-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS, INC. |
| Manufacturer Address | 25651 ATLANTIC OCEAN DR STE A-1 LAKE FOREST CA 92630 US 92630 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-27 |