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 2017-09-21 for IOLMASTER 500 000000-1692-983 manufactured by Carl Zeiss Meditec Ag (jena).
[87188484]
The health care professional (hcp) reported that the measurements from the iolmaster 500 were too large. The hcp further reported that he ordered an incorrect implantable collamer lens (icl) based on the iolmaster measurement values and implanted it in the patient's eye. After the icl surgery, the patient suffered from a glaucoma attack. The hcp could not provide any further details about the event or the patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00018 |
| MDR Report Key | 6884828 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-21 |
| Date of Report | 2017-08-22 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2015-01-09 |
| Date Added to Maude | 2017-09-21 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOLMASTER 500 |
| Generic Name | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED |
| Product Code | HJO |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2017-09-27 |
| Model Number | NA |
| Catalog Number | 000000-1692-983 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-09-21 |