MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for RAINDROP INLAY manufactured by Revision Optics/rvo 2.0 Inc..
[176228631]
I had the raindrop inlay put in my eye. Not only did it not work after more than a year of waiting for my eyes to adjust? To it, it got recalled. Since it was removed, my vision is impaired in the affected eye. Even with glasses, i have blurry distance vision. And i have a very dry eye that is painful at times. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092424 |
| MDR Report Key | 9621955 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-20 |
| Date of Event | 2017-11-10 |
| Date Added to Maude | 2020-01-23 |
| 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 | 3 |
| Brand Name | RAINDROP INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRATIVE |
| Product Code | LQE |
| Date Received | 2020-01-22 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS/RVO 2.0 INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |