MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-07 for VISUMAX FEMTOSECOND LASER 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[130489518]
A device evaluation was not performed since the issue was confirmed to be a software defect in version 2. 10. 13.
Patient Sequence No: 1, Text Type: N, H10
[130489519]
A defect in the smile option of software (sw) version 2. 10. 13 was reported during a wet-lab application training using porcine eyes. If suction loss occurs in phase 2 of the treatment, the software allows the user to choose the option immediate restart or restart treatment. The software offers a flap cut, but due to the software issue, it performs a cap cut instead of a flap cut if the user proceeds. In the case that the user does not recognize the missing side cut of the flap and tries to lift the flap, the patient's cornea could be harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00012 |
| MDR Report Key | 8142799 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-07 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-07 |
| Device Manufacturer Date | 2015-09-08 |
| Date Added to Maude | 2018-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 9255574616 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISUMAX FEMTOSECOND LASER |
| Generic Name | FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION |
| Product Code | OTL |
| Date Received | 2018-12-07 |
| 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 | 2018-12-07 |