D
Patient 1
AFTER UNDERGOING SURGERY TO IMPLANT AN INTRAOCULAR LENS, THE PT EXPERIENCED A POOR POST-OPERATIVE OUTCOME OF +5.00 DIOPTERS. AS A RESULT, THE PT WILL REQUIRE A SECOND SURGERY TO IMPROVE THE POST-OPERATIVE OUTCOME.
MAUDE MDR 2925004
- MDR report key
- 2925004
- Report number
- 9615030-2013-00002
- 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 SECOND OF TWO REPORTABLE EVENTS OCCURRING ON THE SAME DAY AT THIS SITE. THE PT'S SECOND SURGERY HAD NOT BEEN PERFORMED AS OF THE DATE OF THIS REPORT. 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 CONTACT IS THE SAME AS THE INITIAL RPTR.