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 2018-11-01 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[125866304]
Based on review of system log files and the videos captured from each of the surgeries performed, the visumax device worked according to specifications. As reported by the hcp, the issue with the patient's vision was a due to the other hcp's action (i. E. Creation of a "third cut") while removing the lenticule during the smile surgery. A device evaluation was not performed since there was no allegation of a device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[125866305]
On (b)(6) 2018, a healthcare professional (hcp) initiated a circle surgery to improve the visual acuity of a patient that previously underwent a smile surgery performed by a different hcp from the same facility with the same visumax device. Prior to the circle surgery, it was reported that the patient had a visual acuity of 8/10 with refraction on the right eye (od) that cannot be improved with correction. During the circle surgery, after having created the circle cut and during the removal of the flap, the surgeon found that the corneal stroma on the visual axis had been damaged during the smile surgery (by creation of a "third cut") by the other hcp from the same facility. Therefore, the hcp decided to stop the circle surgery. Two days after the circle surgery, the patient's visual acuity was checked by the hcp and reported to be 5/10. The hcp reported that he plans to see the patient again in a month to generate topography images, and perform tomography scans and a slit lamp exam. No further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00010 |
| MDR Report Key | 8029291 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2018-11-01 |
| 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 | 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 |
| 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 | 2018-11-01 |
| 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. Other | 2018-11-01 |