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 2017-05-25 for IOLMASTER 500 000000-1692-983 manufactured by Carl Zeiss Meditec Ag (jena).
[76020480]
A zeiss field service engineer inspected the iolmaster 500 and confirmed that it is working within manufacturer specification. The manufacturer evaluated pre-op measurement and iol calculation printouts from the device. These printouts do not show any abnormality. The device measures within specification. The calculation of the iol power performed by the device was correct. During the investigation, the customer informed that the patient removed contact lenses the same day of measurement and the use of lubricating drops was required. A number of factors not related to the iolmaster may have influenced the surgical outcome. The risk of measuring errors, including contact lens use and tear film, is described in detail in the user manual on page 7 (000000-1692-983-doks-us-170413). The quality of k-measurement highly depends on stable tear film, correct fixation, and wide open eyes. The user manual describes in detail how to perform intraocular lens measurements and calculations and contains warnings about relevant parameters. .
Patient Sequence No: 1, Text Type: N, H10
[76020481]
The health care professional (hcp) reported the following: the os post-refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed from the target refraction. The alcon acrysof iq model sn60wf lens was used. The hcp did not inform about the lens power used or the post-op refraction. The hcp made a decision to exchange the iol. The same lens with a power of 16. 5 d was used for the re-op. The iolmaster was used for the biometry measurements and iol calculations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00008 |
| MDR Report Key | 6591807 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-03-21 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2014-10-16 |
| Date Added to Maude | 2017-05-25 |
| 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. 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, THUERINGIA 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 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-05-25 |
| Model Number | NA |
| Catalog Number | 000000-1692-983 |
| 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 | 1. Other | 2017-05-25 |