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 2688052
- MDR report key
- 2688052
- Report number
- 9615030-2009-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-08-01
- Date received
- 2009-12-22
- 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 | IOL MASTER | SLITLAMP, BIOMECROSCOPE | CARL ZEISS MEDITEC AG | HJO | IOL5-12 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-12-22 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE IOLMASTER WAS INSPECTED BY SERVICE TECHNICIAN AND FOUND TO BE OPERATING PROPERLY AND IN CALIBRATION. THE IMPLANTATION OF THE WRONG INTRAOCULAR LENS OF THE LEFT EYE MAY HAVE BEEN POTENTIALLY CAUSED BY AN INTRAOCULAR EYE PRESSURE EXAMINATION WITH A CONTACT TONOMETER PRIOR TO THE IOL MASTER MEASUREMENT. USE OF A CONTACT TONOMETER COMPRESSES THE CORNEA OF THE EYE AND MAY IMPACT THE RESULTS OF THE EYE'S BIOMETRIC MEASUREMENTS. THE IOLMASTER USER MANUAL CAUTIONS AGAINST APPLANATING THE EYE PRIOR TO OBTAINING MEASUREMENTS WITH IOLMASTER. FOLLOWING THIS INCIDENT THE SITE'S PERSONNEL WERE INSTRUCTED IN PROPER OPERATION BY A CLINICAL APPLICATION SPECIALIST.