D
Patient 1
THE SITE REPORTED THAT THERE WERE 5 POST-IMPLANTATION REFRACTIVE SURPRISES REQUIRING RE-IMPLANTATION OVER THE PAST YEAR. THIS IS THE INFO FOR PT 4/5. THE INFO FOR PT 4/5 HAS NOT BEEN PROVIDED.
MAUDE MDR 3040148
- MDR report key
- 3040148
- Report number
- 9615030-2013-00007
- Event key
- 0
- Event type
- 3
- Date received
- 2013-04-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JUDY BRIMACOMBE
- 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 | IOLMASTER 500 | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | CARL ZEISS MEDITEC AG (JENA SITE) | HJO | 500 | 000001-4184-141 | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-04-03 | 0 | 1. R |
Event Narratives#
N
Patient 1
A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE INSPECTION OF THE IOLMASTER 500. THE INSTRUMENT WAS FOUND TO BE WORKING WITHIN SPECIFICATIONS FOR THOSE PARAMETERS THAT AFFECT THE IOL CALCULATION INCLUDING AXIAL LENGTH, KERATOMETRY, WHITE-TO-WHITE AND ANTERIOR CHAMBER DEPTH MEASUREMENTS. THE INSTRUMENT WAS FOUND TO BE OUT OF SPECIFICATION FOR SLED SPEED AND AXIAL LENGTH END LIMITS. THE MEASUREMENT HEAD WAS REPLACED TO ADDRESS THE END LIMITS AND THE INSTRUMENT WAS DETERMINED TO BE WORKING WITHIN SPECIFICATION. THE MANUFACTURER'S EVALUATION OF THE ROOT CAUSE IS ONGOING. SITE CONTACT: SAME AS INITIAL REPORTER.