MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for RAINDROP INLAY RD1-1 manufactured by Rvo 2.0, Inc..
[140583520]
I had the rain drop implanted in my left eye on (b)(6) 2018. I had a horrible experience. A few hours after surgery, i had severe (crying) pain. I couldn't read my computer for work. The starburst and glares were terrible. I was afraid i would get into an accident while driving, due to object being so distorted. I found myself getting off the road because i couldn't be sure which lane cars were in. It was too hazardous for me to drive at night. I could read the eye chart, but the black letters were blurry, light gray in color and distorted. I was told that my vision had greatly improved, impossible. My raindrop was removed a year later. I'm experiencing sharp pain in my eye, headaches, twitching of the eye and constant dry eye. I'm back to using eye glasses. I'm concerned this nightmare is not over. Ridiculous. Class 1 recall of all devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085424 |
| MDR Report Key | 8470635 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-27 |
| Date of Event | 2018-01-05 |
| Date Added to Maude | 2019-04-01 |
| 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 | 2019-03-29 |
| Model Number | RD1-1 |
| Catalog Number | RD1-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RVO 2.0, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-29 |