MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-11 for VISUMAX LASER KERATOME NI manufactured by Carl Zeiss Meditec Ag (jena).
[119927851]
The available information was reviewed and no matching complaint was identified with the event reported on the voluntary event report mw5078745. No additional information about patient, device, or health care professional (hcp) could be obtained from the voluntary event report or the maude database. Xerophthalmia or dry eye is documented as a potential risk of the smile procedure in the visumax instruction for use.
Patient Sequence No: 1, Text Type: N, H10
[119927852]
Carl zeiss meditec, inc. Received from the fda a voluntary event report mw5078745, which was submitted by a health care professional (hcp). In the voluntary report, the hcp reported that a patient experienced severe xerophthalmia post refractive correction surgery using the visumax laser system. The physician did not allege a device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00005 |
| MDR Report Key | 7866702 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-09-11 |
| 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 | VISUMAX LASER KERATOME |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OTL |
| Date Received | 2018-09-11 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2018-09-11 |