D
Patient 1
A PT REQUIRED ADD'L SURGERY TO REMOVE A PREVIOUSLY IMPLANTED INTRAOCULAR LENS AND TO IMPLANT A DIFFERENT INTRAOCULAR LENS.
MAUDE MDR 1469110
- MDR report key
- 1469110
- Report number
- 9615030-2009-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-02-19
- Date received
- 2009-08-26
- 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 DR 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 | SLITLAMP, BIOMICROSCOPE | CARL ZEISS MEDITEC AG | HJO | IOL5-12 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-08-26 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE IOLMASTER WAS INSPECTED BY A SERVICE TECHNICIAN AND FOUND TO BE OPERATING PROPERLY AND WITHIN CALIBRATION. THE IMPLANTATION OF THE WRONG INTRAOCULAR LENS IN THE LEFT EYE COULD HAVE POTENTIALLY BEEN CAUSED BY AN INTRAOCULAR EYE PRESSURE EXAMINATION WITH A CONTACT TONOMETER PRIOR TO THE IOLMASTER MEASUREMENT. USE OF A CONTACT TONOMETER COMPRESSES THE CORNEA OF THE EYE AND MAY IMPACT THE RESULTS OF THE EYE'S BIOMETRIC MEASUREMENTS. IOLMASTER USER MANUAL PROVIDES INSTRUCTIONS REGARDING CONTACT MEASUREMENTS PRIOR TO MEASURING THE EYES WITH IOLMASTER. THE SITE'S PERSONNEL WERE INSTRUCTED IN PROPER OPERATION BY A CLINICAL APPLICATION SPECIALIST.