N
Patient 1
MAUDE MDR 6659316
- MDR report key
- 6659316
- Report number
- 9615030-2017-00012
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-05-23
- Date received
- 2017-06-21
- Adverse event
- 3
- 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. GARY GUSTAFSON
- 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 LASER KERATOME | LASER, OPHTHALMIC | CARL ZEISS MEDITEC AG (JENA) | HQF | NA | 000000-1345-518 | NA | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-21 | 0 |
Event Narratives#
D
Patient 1
THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT AN IRREGULAR SURFACE CUTTING OCCURRED ON THE PATIENT'S EYE DURING FLAP CREATION WITH THE VISUMAX. THE HCP MADE A DECISION TO STOP TREATMENT BEFORE LIFTING THE FLAP AND PERFORMING ABLATION OF THE CORNEAL TISSUE. THE PATIENT WAS TREATED WITH ANOTHER VISUMAX IN THE SAME CLINIC. THE PROVIDED PRE- AND POST-OP REFRACTION DATA INDICATE THE PATIENT'S VISUAL ACUITY IMPROVED FROM 1.0 TO 1.2 FOR BOTH EYES. ALL PERTINENT INFORMATION AVAILABLE TO CARL ZEISS MEDITEC HAS BEEN SUBMITTED IN THIS REPORT.