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 2018-01-18 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[97712927]
As the reported event occurred more than 3 years ago, the manufacturer reviewed the service records for visumax serial number (b)(4), which show that the device was working within specification during the time period of the event. Ectasia is documented as a potential risk of the smile procedure in the visumax professional use information and patient information booklets. It is necessary to treat ectasia to prevent its progression and to preserve visual potential.
Patient Sequence No: 1, Text Type: N, H10
[97712928]
The health care professional (hcp) reported that a patient came back for a vision checkup more than three years after a smile refractive treatment was performed using the visumax laser keratome. The hcp diagnosed corneal ectasia of the left eye, which had not been detected by the patient. The hcp did not find any issue with the patient's right eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00001 |
| MDR Report Key | 7204536 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-18 |
| Date of Report | 2017-12-19 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2008-07-23 |
| Date Added to Maude | 2018-01-18 |
| 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. 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 |
| 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 | 2018-01-18 |
| Model Number | NA |
| Catalog Number | 000000-1345-518 |
| Lot Number | NA |
| 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 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-18 |