MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for RAINDROP CORNEAL INLAY manufactured by Revision Optics / Rvo 2.0, Inc..
[141105299]
Fin (b)(6) 2017, i had a raindrop corneal inlay implanted in my right eye. One year later in (b)(6) 2018, i developed corneal haze which affected my vision. I had the lens replaced and the haze was treated. Approx 1 yr later in (b)(6) 2019, i developed the haze again and this time caused headaches. Blurred vision, and loss of depth perception. On (b)(6) , i had the inlay removed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085602 |
| MDR Report Key | 8487179 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-03-22 |
| Date Added to Maude | 2019-04-05 |
| 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 CORNEAL INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRACTIVE - RAINDROP POOR VISION INLAY |
| Product Code | LQE |
| Date Received | 2019-04-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS / RVO 2.0, INC. |
| Brand Name | RAINDROP CORNEAL INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRACTIVE - RAINDROP POOR VISION INLAY |
| Product Code | LQE |
| Date Received | 2019-04-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS / RVO 2.0, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 81 | 1. Other; 2. Required No Informationntervention | 2019-04-04 |