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 2018-10-05 for IOLMASTER 700 N/A 000000-1932-169 manufactured by Carl Zeiss Meditec Ag (jena).
[123051646]
Review of the patient's measurement data showed that the patient's retina was not correctly identified by the iolmaster 700. The retina signal was superimposed by an oct scan artifact resulting from fingerprints on the front lens of the iolmaster. The device algorithms identified the artifact as the retina structure. This caused pre op measuring error for axial length. The user manual describes in detail how to evaluate measurement quality and contains warnings about relevant parameters. Proper cleaning of optical surfaces is also described in the user manual.
Patient Sequence No: 1, Text Type: N, H10
[123051647]
A health care professional (hcp) reported that there had been an incorrect hyperopic surgical result after using the iolmaster 700 for the biometry measurements and lens power calculations. The hcp reported that a lens exchange will be performed to correct the patient's vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00007 |
| MDR Report Key | 7940713 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-05 |
| Date of Report | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2018-10-05 |
| 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 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 | 2018-10-05 |
| Model Number | N/A |
| Catalog Number | 000000-1932-169 |
| Lot Number | N/A |
| 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 7745 GM 7745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-05 |