N
Patient 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4)
MAUDE MDR 7872309
- MDR report key
- 7872309
- Report number
- 2028159-2018-01928
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-08-20
- Date received
- 2018-09-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CINDY MILAM
- Address
- 6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
- Phone
- 817-817-8176
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUXOR OPHTHALMIC MICROSCOPES | MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER | HRM | LX3 | 8065753064 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-13 | 0 |
Event Narratives#
D
Patient 1
A CUSTOMER REPORTED THAT DURING SETUP FOR SURGERY, IT WAS NOTICED THAT THE COMMUNICATION SYSTEM TOUCHSCREEN IS LOOSE ON THE MICROSCOPE.