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 2017-06-15 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[77703494]
The manufacturer reviewed on-site service documentation which confirmed that the device was working within specification. The investigation has not identified any abnormality or product deficiency related to the incident. The manufacturer evaluated the log files and treatment protocols from the device. The data indicated that the laser energy value was set very high at 40 (200 nj) during the visumax smile treatment. The user manual (ifu 000000-1345-518-doks-sm-gb-160514, page 29) advises the hcp that changes in parameters should only be made in consultation with the attending application specialist. The user manual also cautions the hcp that the parameters may have an impact on the clinical results , e. G. , post-operative visual acuity.
Patient Sequence No: 1, Text Type: N, H10
[77703495]
The health care professional (hcp) from (b)(6) reported a bad refractive outcome. The patient lost more than two lines of bscva (best-corrected visual acuity) after visumax smile treatment. The hcp made a decision to refer the patient to another hcp. The second hcp re-treated this patient on (b)(6) 2017. The patient's post-operative ucva (uncorrected visual acuity) after the second treatment was 6/6 od and 6/12 os. All pertinent information available to carl zeiss meditec has been submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00010 |
| MDR Report Key | 6645787 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-04-06 |
| Date Mfgr Received | 2017-05-16 |
| Device Manufacturer Date | 2016-04-16 |
| Date Added to Maude | 2017-06-15 |
| 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 |
| 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 | 2017-06-15 |
| 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 07745 GM 07745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-06-15 |