N
Patient 1
A DEVICE EVALUATION WAS NOT PERFORMED SINCE THE ISSUE WAS CONFIRMED TO BE A SOFTWARE DEFECT IN VERSION 2.10.13.
MAUDE MDR 8142799
- MDR report key
- 8142799
- Report number
- 9615030-2018-00012
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-07
- Date received
- 2018-12-07
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. VERNON BROWN
- Address
- 5160 HACIENDA DRIVE DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VISUMAX FEMTOSECOND LASER | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION | CARL ZEISS MEDITEC AG (JENA) | OTL | NA | 000000-1345-518 | NA | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-07 | 0 |
Event Narratives#
D
Patient 1
A DEFECT IN THE SMILE OPTION OF SOFTWARE (SW) VERSION 2.10.13 WAS REPORTED DURING A WET-LAB APPLICATION TRAINING USING PORCINE EYES. IF SUCTION LOSS OCCURS IN PHASE 2 OF THE TREATMENT, THE SOFTWARE ALLOWS THE USER TO CHOOSE THE OPTION IMMEDIATE RESTART OR RESTART TREATMENT. THE SOFTWARE OFFERS A FLAP CUT, BUT DUE TO THE SOFTWARE ISSUE, IT PERFORMS A CAP CUT INSTEAD OF A FLAP CUT IF THE USER PROCEEDS. IN THE CASE THAT THE USER DOES NOT RECOGNIZE THE MISSING SIDE CUT OF THE FLAP AND TRIES TO LIFT THE FLAP, THE PATIENT'S CORNEA COULD BE HARMED.