MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for FEMTOSECOND LASER (SMILE) manufactured by Carl Zeiss Meditec.
[115823435]
Severe xerophthalmia post refractive correction surgery (smile method) just for helping to reduce the complications of this method. Thanks by the way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078745 |
| MDR Report Key | 7739176 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-29 |
| Date of Event | 2018-05-04 |
| Date Added to Maude | 2018-08-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | FEMTOSECOND LASER (SMILE) |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OTL |
| Date Received | 2018-07-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC |
| Brand Name | FEMTOSECOND LASER (SMILE) |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OOE |
| Date Received | 2018-07-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-31 |