MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for RAINDROP INLAY manufactured by Revision Optics, Incorporated.
[128180578]
I had a raindrop inlay implanted in (b)(6) 2017. I almost immediately had problems with haziness in that eye and it has progressively gotten worse. I was just told to see my ophthalmologist and he suggested steroids, but i am very upset and confused. I wish the fda and my doctor had told patients that this was just experimental still and/or that i had had access to better advice from the start. Very, very unhappy about this inlay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081455 |
| MDR Report Key | 8089417 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-15 |
| Date Added to Maude | 2018-11-20 |
| 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 INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRACTIVE |
| Product Code | LQE |
| Date Received | 2018-11-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS, INCORPORATED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-19 |