MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-16 for FEMTO FEMTO Z4 PP 510.003.004 manufactured by Sie Ag, Surgical Instrument Engineering.
[187258921]
Pt underwent lasik ou (b)(6) 2019. Developed dlk od, steroid pf increased to qhr od. Flap lift (b)(6) 2019 od. (b)(6) 2019 po vasc 20/40 od, 20/20 os. Rxm od no improvement. Will continue to monitor as epi remodels. Ar approx +2. 50 at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005643720-2020-00001 |
| MDR Report Key | 9595312 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-11-23 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2018-04-30 |
| Date Added to Maude | 2020-01-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PHD MICHELA PEISINO |
| Manufacturer Street | ALLMENDSTRASSE 11 |
| Manufacturer City | PORT, BE CH-2562 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-2562 |
| Manufacturer G1 | SIE AG, SURGICAL INSTRUMENT ENGINEERING |
| Manufacturer Street | ALLMENDSTRASSE 11 |
| Manufacturer City | PORT, CH-2562 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMTO |
| Generic Name | FEMTO LDV Z4 |
| Product Code | HQF |
| Date Received | 2020-01-16 |
| Model Number | FEMTO Z4 PP |
| Catalog Number | 510.003.004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIE AG, SURGICAL INSTRUMENT ENGINEERING |
| Manufacturer Address | ALLMENDSTRASSE 11 PORT, CH-2562 SZ CH-2562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |