D
Patient 1
A CUSTOMER REPORTED THAT DURING A VITRECTOMY PROCEDURE THERE WAS A PROBLEM WITH THE ILLUMINATION SOURCE. THE SYSTEM WAS RESTARTED AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.
MAUDE MDR 4860222
- MDR report key
- 4860222
- Report number
- 2028159-2015-06585
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-26
- Date received
- 2015-06-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. EDDIE DARTON, MD, JD
- Address
- 6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
- Phone
- 817-817-8175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM | ENDOILLUMINATOR | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER | MPA | NA | 8065750290 | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-22 | 0 | 1. O |
Event Narratives#
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).
N
Patient 1
ADDITIONAL INFORMATION: THE SYSTEM WAS EXAMINED. THE COMPANY REPRESENTATIVE DID NOT INDICATE FINDING ANY ISSUES THAT WOULD BE ASSOCIATED WITH THE REPORTED EVENT. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER?S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE LIGHT SOURCE WAS MANUFACTURED ON MAY 19, 2010. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).