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 2017-07-28 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[81363478]
A zeiss field service engineer (fse) inspected the visumax laser keratome on site and confirmed that the device is working within specification. The manufacturer reviewed the on-site service documentation which confirmed that the device was working within specification in the time period of the reported incident. A number of factors not related to the visumax device may have influenced the surgical outcome. The manufacturer reviewed the document labelling for visumax laser keratome. Difficult lenticule extraction is a potential risks that can be associated with the smile refractive procedure. The user manual ((b)(4)) advises the hcp to perform a clinical evaluation to identify any additional risks and side effects from the relevant technical literature and medical associations.
Patient Sequence No: 1, Text Type: N, H10
[81363479]
Health care professional (hcp) reported difficulty in extracting lenticule during a smile refractive treatment using the visumax laser keratome. The hcp was unable to extract the entire lenticule and a small part of the lenticule remained in the patient's eye. The hcp performed an additional surgery to remove the remaining lenticule. No adverse consequences to the patient are known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00014 |
| MDR Report Key | 6752016 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-28 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2016-02-15 |
| Date Added to Maude | 2017-07-28 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| 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 | 2017-07-28 |
| Model Number | NA |
| Catalog Number | 000000-1345-518 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (JENA) |
| Manufacturer Address | CARL ZEISS PROMENADE 10 JENA, THUERINGIA 1154546 GM 1154546 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-28 |