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 2019-03-14 for VISUMAX LASER KERATOME N/A 000000-1741-582 manufactured by Carl Zeiss Meditec Ag (jena).
[138824868]
The retained samples of the treatment pack, which is an accessory to the visumax product, were checked for any break in the sterile barrier. The results were within specification. No abnormalities were found. Root cause for the staphylococcal infection cannot be determined. Staphylococcal infection can not be caused by the visumax device nor is the infection described as a side effect.
Patient Sequence No: 1, Text Type: N, H10
[138824869]
A health care professional (hcp) reported that two days after going through a visumax smile procedure, the patient had to be hospitalized due to abscesses on both eyes. The patient had a central abscess on the right eye and a peripheral abscess, more diffused, on the left eye. The patient was diagnosed with a staphylococcal infection and was treated at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2019-00003 |
| MDR Report Key | 8421699 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-14 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2010-10-19 |
| Date Added to Maude | 2019-03-14 |
| 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 |
| 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 | 2019-03-14 |
| Model Number | N/A |
| Catalog Number | 000000-1741-582 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-03-14 |