MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for RAIN DROP CORNEAL INLAY manufactured by Revision Optics/ Rvo 2.0, Inc.
[141023785]
Had rain drop corneal inlay implanted in left eye approximately 2015-16. Developed vision problems and when i went in for a yearly eye check (032119) was informed of a recall of the lens and sent immediately to have it removed. The lens was removed on (b)(6) 2019 after i made an appointment. Did not receive information of the recall or any possible corneal haze, inflammation which could have lead to infection, issues i had been experiencing over the past year. I am experiencing post op dry eye along with irritation since the removal and being treated with steroids and antibiotics. Left eye blurry. Fda safety report id #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085570 |
| MDR Report Key | 8482809 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-21 |
| Date Added to Maude | 2019-04-04 |
| 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 | RAIN DROP CORNEAL INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRACTIVE |
| Product Code | LQE |
| Date Received | 2019-04-03 |
| 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. Other; 2. Required No Informationntervention | 2019-04-03 |