MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2018-12-21 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[131302578]
The manufacturer reviewed the 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 reviewed the document labelling for visumax laser keratome. The user manual (ifu 000000-1345-518-doks-sm-kr-211114, p. 6-9) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure. Moreover the user manual describes headache, dry eye, visual disturbance as side effects that can be associated with the visumax laser procedure. The user manual also advises the healthcare professional to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations.
Patient Sequence No: 1, Text Type: N, H10
[131302579]
On 11/29/2018, carl zeiss meditec (czm) received a voluntary report (mw5081613) from the fda submitted by a patient who underwent a relex smile surgery on (b)(6) 2018 with the visumax device and collagen-cross linking (cxl). Cxl is a treatment that is provided by a third party company and it is not in the responsibility of czm. Per the report, the patient's eye sight was not corrected to 1. 0 after the surgery - the patient's vision on the left eye was reported to be 0. 5 while the right eye was reported to be 0. 6. The patient reported seeking other doctors' opinions. They communicated to the patient that this is an irregular astigmatism which cannot be corrected by glasses. The patient reported experiencing numerous side effects such as headaches, nausea, double vision, blurry vision, ghosting, glare, starburst, shadows, dry eye, eye burning, eye pain, floaters and ectasia. Treatment videos and patient information were requested from the eye clinic in (b)(6), but due to local regulations, it has not been provided. The patient's pre-operative conditions are currently unknown and stable post-operative information were not provided for each eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2018-00014 |
| MDR Report Key | 8192604 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2018-12-21 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-07-04 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2018-12-21 |
| 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 | 2018-12-21 |
| 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 | 2018-12-21 |