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 2017-03-11 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).
[69734556]
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-ga-sm-fr-290811, page 7 and 8) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure. The user manual also advises the hcp 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
[69734557]
The health care professional (hcp) reported a case of suspected corneal ectasia for a patient post visumax laser keratome treatment. The hcp also reported that the separation of the lenticle was difficult during treatment. After one year and three months post treatment the patient's uncorrected visual acuity is 4/10 and corrected visual acuity is 7/10, -1. 00(-1. 50) 40?. All pertinent information available to carl zeiss meditec has been submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615030-2017-00004 |
| MDR Report Key | 6397754 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-11 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2012-12-11 |
| Date Added to Maude | 2017-03-11 |
| 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 | 2017-03-11 |
| 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. Deathisabilit | 2017-03-11 |