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 2019-03-22 for IOLMASTER 700 N/A 000000-2181-545 manufactured by Carl Zeiss Meditec Ag (jena).
[139601493]
Patient Sequence No: 1, Text Type: N, H10
[139601494]
A health care professional (hcp) reported that there had been an incorrect surgical result after using the iolmaster 700 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 | 9615030-2019-00004 |
| MDR Report Key | 8445120 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-22 |
| Date of Report | 2019-02-20 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 700 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2019-03-22 |
| Model Number | N/A |
| Catalog Number | 000000-2181-545 |
| 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 | 2019-03-22 |