MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-04 for IOLMASTER V 4.08 * manufactured by Carl Zeiss.
[17724816]
Iol master screening was done pre-op for cataract surgery, r eye reading accurate, l eye reading innaccurate but no alarm or highlight related to the size discrepancy. Cataract size ordered as indicated by test result and on post op day one patient found to have worse vision and it was determined that the wrong size lens was implanted. ====================== health professional's impression======================instead of rejecting a false measurement, the machine used it to incorrectly calculate a wrong lens implant size. This is because when the cataract is too dense, the iolmaster can not give an accurate measurement. Instead of reporting an erroneous measurement, it should indicate the need for a different test. It may be helpful to allow for calibration of the software if the test is inaccurate. The physician realizes there are human factors involved but feels there could be an improvement to the software/reporting out of results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717016 |
| MDR Report Key | 1717016 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-04-22 |
| Date of Event | 2010-01-26 |
| Report Date | 2010-04-22 |
| Date Reported to FDA | 2010-05-04 |
| Date Added to Maude | 2010-06-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER |
| Generic Name | INTRAOCULAR LENS TESTING |
| Product Code | HLM |
| Date Received | 2010-05-04 |
| Model Number | V 4.08 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS |
| Manufacturer Address | 5160 HACIENDA DR. DUBLIN CA 94568 US 94568 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-04 |