Trade Name: LenSx Laser System /// registration: 80153480158 // risk class III Lot-series: 413-A364; 0713-A450; 0414-A727; 0714-A808; 0714-A802; 1213-A620; 1213-A621; 1213-A622; 1013-A535 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Recommendations to Users and Patients of the Record Holder of This Product: "Incomplete flap cuts are known to occur during LASIK procedures and their proper handling is part of the surgeon's training. We urge you to exercise your medical judgment in determining your level of comfort while handling potential cuts, which may occur as a result of your continued use of the LenSx Laser System in performing flap upgrades. According to the user manual of the LenSx Laser System, in the case of an incomplete laser treatment during the flap procedure, where a lateral cut is performed or not, it is advised that the corneal flap is not lifted. The surgeon should consider other medical options more suitable to complete the refractive treatment. We are informing all users of flap upgrade of this possibility and we will update the software of all LenSx Laser System equipment that are used to perform corneal flap, in order to minimize the frequency of potentially incomplete areas at the flap edge. "