N
Patient 1
THE CUSTOMER WAS REQUESTED TO PUT THE IOLMASTER 700 OUT OF SERVICE AND TO RETURN THE DEVICE FOR EVALUATION BY THE MANUFACTURER. SO FAR THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.
MAUDE MDR 8240760
- MDR report key
- 8240760
- Report number
- 9615030-2019-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-12-13
- Date received
- 2019-01-11
- 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. 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 | IOLMASTER 700 | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | CARL ZEISS MEDITEC AG (JENA) | HJO | 700 | 000000-1932-169 | N/A | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-11 | 0 |
Event Narratives#
D
Patient 1
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE AXIAL LENGTH (AL) MEASUREMENTS OF STAFF MEMBERS TAKEN ON AN IOLMASTER 700 ARE IN AVERAGE 0.06 MM GREATER THAN THE AL MEASUREMENTS TAKEN ON AN IOLMASTER 500. THE HCP CONFIRMED THAT THE TEST EYE MEASUREMENTS OF THE IOLMASTER 500 WERE WITHIN SPECIFICATION. IT CANNOT BE CONFIRMED THAT THE IOLMASTER 700 DID NOT MALFUNCTION. ANY EVENT OF AN UNEXPECTED REFRACTIVE RESULT ON A PATIENT, USING THE SUSPECT IOLMASTER 700, ARE NOT KNOWN.