MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-03-03 for IOLMASTER 000000-1322-734 manufactured by Carl Zeiss Meditec Ag (jena).
[39629886]
A field service engineer performed an on-site examination of the iolmaster. No deviation in the readings for axial length, keratometry, anterior chamber depth, or white-to-white were found. The healthcare provider made a decision to proceed with the original implantation although the measurement printout showed different od and os k-values and included the remark: "the ker- readings should be checked for plausibility, as there might be pathological changes. " the quality of the k-measurement highly depends upon the quality of the tear film, correct fixation and wide open eyes.
Patient Sequence No: 1, Text Type: N, H10
[39629887]
The health care professional reported the following: the post refractive outcome for an eye cataract surgery with intraocular lens (iol) implantation was od -2. 75 diopters. The healthcare professional made a decision to exchange the iol. The iolmaster was used for the original biometry measurements and iol calculations as well as for the second biometry measurements and calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2016-00002 |
| MDR Report Key | 5478523 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-03 |
| Date of Report | 2016-03-03 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2008-03-08 |
| Date Added to Maude | 2016-03-03 |
| 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 | MS. WILLIAM GUSTAFSON |
| 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, THURINGIA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED, PRODUCT CODE: HJO |
| Product Code | HJO |
| Date Received | 2016-03-03 |
| Model Number | NA |
| Catalog Number | 000000-1322-734 |
| 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, THURINGIA 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-03 |