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 2017-09-22 for IOLMASTER 700 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[87207733]
A zeiss field service engineer inspected the iolmaster 700 and confirmed that it is working within manufacturer specification. The manufacturer reviewed provided service protocols, the pre- and post-op measurement and iol calculation printouts from the device. These printouts do not show any abnormality. The calculation of the iol power performed by the device was correct. The data provided show two warnings/caution indicators: short eye and borderline signal quality indicator. Axial length should be taken into consideration for iol calculation using suitable formulae. In addition, according to the user manual, when one or more yellow signal quality indicators appear, repeat measurements are recommended prior to a final clinical determination. A number of factors not related to the lolmaster may have influenced the surgical outcome. The user manual describes in detail how to perform intraocular lens measurements and calculations and contains warnings about relevant parameters. The risk of measuring errors is described in detail on page 7 of the user manual (000000-1932-169-doks-us-070815).
Patient Sequence No: 1, Text Type: N, H10
[87207734]
The healthcare professional (hcp) reported the following:the iolmaster was used for the original biometry measurements. The os post-refractive outcome after a cataract surgery with an intraocular lens (iol) implantation differed +1. 00 d from the target refraction. The bausch and lomb crystalens ao lens with a power of +28. 00d was used. The hcp made a decision to exchange the iol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00020 |
| MDR Report Key | 6888247 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-22 |
| Date of Report | 2017-08-23 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-08-23 |
| Device Manufacturer Date | 2015-11-10 |
| Date Added to Maude | 2017-09-22 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-09-22 |
| Model Number | NA |
| 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 | 1. Other | 2017-09-22 |