MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-19 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[112347346]
Patient Sequence No: 1, Text Type: N, H10
[112347347]
The axial length (al) measurement values of an iolmaster 700 demo unit are incorrect. This would lead to an al error of approximately 0. 25mm, which would result in an intraocular lens error of approximately 0. 8 diopter. This in turn would result in a refractive error of about 0. 5 diopter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00002 |
| MDR Report Key | 7617532 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-19 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-05-21 |
| Date Mfgr Received | 2018-05-21 |
| Device Manufacturer Date | 2017-09-18 |
| Date Added to Maude | 2018-06-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 945687562 |
| Manufacturer Country | US |
| Manufacturer Postal | 945687562 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMETER |
| Product Code | HJO |
| Date Received | 2018-06-19 |
| Model Number | 700 |
| Catalog Number | 000000-1932-169 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-19 |