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 2018-10-18 for IOLMASTER 500 N/A 266002-1141-139 manufactured by Carl Zeiss Meditec Ag (jena).
[124312673]
The manufacturer reviewed the patient's pre- and post-op measurement data and the iol calculation printouts from the device. These printouts do not show any abnormality. The measurement data indicates that the iolmaster 500 provided the correct iol power of 3 diopters. However, the user chose and implanted a negative 3 diopters iol, causing the reported refractive outcome. The user manual describes in detail how to perform intraocular lens measurements and calculations and contains warnings about relevant parameters. The user manual also describes the risk of measuring errors in detail.
Patient Sequence No: 1, Text Type: N, H10
[124312674]
A health care professional (hcp) reported that there had been an incorrect surgical result after using the iolmaster 500 for the biometry measurements and lens power calculations. The hcp reported that a lens exchange has been performed to correct the patient's vision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00008 |
| MDR Report Key | 7981030 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-18 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2011-10-19 |
| Date Added to Maude | 2018-10-18 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2018-10-18 |
| Model Number | N/A |
| Catalog Number | 266002-1141-139 |
| 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 | 2018-10-18 |