MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-01-11 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[132938868]
The customer was requested to put the iolmaster 700 out of service and to return the device for evaluation by the manufacturer. So far the device has not been returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
[132938869]
A health care professional (hcp) reported that the axial length (al) measurements of staff members taken on an iolmaster 700 are in average 0. 06 mm greater than the al measurements taken on an iolmaster 500. The hcp confirmed that the test eye measurements of the iolmaster 500 were within specification. It cannot be confirmed that the iolmaster 700 did not malfunction. Any event of an unexpected refractive result on a patient, using the suspect iolmaster 700, are not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2019-00001 |
| MDR Report Key | 8240760 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-11 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2016-11-28 |
| Date Added to Maude | 2019-01-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VERNON BROWN |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Street | CARL ZEISS PROMENADE 10 |
| Manufacturer City | JENA, THUERINGIA 7745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 7745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2019-01-11 |
| Model Number | 700 |
| Catalog Number | 000000-1932-169 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA 7745 GM 7745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-11 |