D
Patient 1
AFTER UNDERGOING SURGERY TO IMPLANT AN INTRAOCULAR LENS, THE PT EXPERIENCED A POOR POST-OPERATIVE OUTCOME OF +3.00 DIOPTERS. AS A RESULT, THE PT REQUIRED A SECOND SURGERY TO IMPROVE THE POST-OPERATIVE OUTCOME.
MAUDE MDR 2925005
- MDR report key
- 2925005
- Report number
- 9615030-2013-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-11-26
- Date received
- 2013-01-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | CARL ZEISS MEDITEC AG (JENA SITE) | HJO | NA | 000001-1703-031 | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-17 | 0 | 1. O |
Event Narratives#
N
Patient 1
THIS IS THE FIRST OF TWO REPORTABLE EVENTS OCCURRING ON THE SAME DAY AT THIS SITE. THE PT'S SECOND SURGERY WAS PERFORMED. A FIELD SERVICE ENGINEER PERFORMED AN ON-SITE EVAL OF THE IOLMASTER INSTRUMENT AND VERIFIED FULL FUNCTIONALITY OF THE INSTRUMENT. A REVIEW OF THE PT'S IOLMASTER DATA PRINTOUT BY MFR'S TECHNICAL REPS FOUND NO PROBLEMS. A CUSTOMER REP REPORTED THAT USER ERROR CONTRIBUTED TO THE SELECTION OF THE WRONG IOL; THE ORDER OF THE SELECTED IOLS PRESENTED IN THE IOLMASTER PRINTOUT (WHICH IS UNDER THE CONTROL OF THE OPERATOR) WAS DIFFERENT FROM THE ORDER TYPICALLY EXPECTED BY THE DOCTOR. NOTE: SITE IS THE SAME AS THE INITIAL RPTR.