MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for LASIK EYE SURGERY manufactured by .
[58181754]
Night vision after lasik eye surgery in 2004 at (b)(6) became so eroded that i have been unable to drive at night or in low light since 2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065543 |
| MDR Report Key | 6046783 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-10-18 |
| Date of Event | 2009-10-01 |
| Date Added to Maude | 2016-10-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | LASIK EYE SURGERY |
| Generic Name | LASIK EYE SURGERY |
| Product Code | LQJ |
| Date Received | 2016-10-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Brand Name | LASIK EYE SURGERY |
| Generic Name | LASIK EYE SURGERY |
| Product Code | OJK |
| Date Received | 2016-10-18 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-10-18 |