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.
[128180581]
Decreased visual acuity and corneal haze.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081484 |
| MDR Report Key | 8089976 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-16 |
| Date of Event | 2016-12-17 |
| 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 | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Lot Number | 002990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS INCORPORATED |
| Manufacturer Address | US |
| Brand Name | RAINDROP INLAY |
| Generic Name | IMPLANT, CORNEAL, REFRACTILE |
| Product Code | LQE |
| Date Received | 2018-11-19 |
| Lot Number | 002990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REVISION OPTICS INCORPORATED |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-19 |