Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
데이터 추가 비고
원인
Through remote monitoring of the intraocular lens (iol) databases on installed ora carts alcon has determined that that a small number of ora carts have the potential to return an incorrect iol power measurement during cataract surgery.
Model Catalog: ORA SYSTEM 2000 (Lot serial: C4286R); Model Catalog: 00380659983078 (Lot serial: C4239R); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601274801X1); Model Catalog: 00380659983078 (Lot serial: 1601274801X1); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601320201X1); Model Catalog: 00380659983078 (Lot serial: 1601320201X1); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601321601X); Model Catalog: 00380659983078 (Lot serial: 1601321601X); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601321301X); Model Catalog: 00380659983078 (Lot serial: 1601321301X); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1603716401X); Model Catalog: 00380659983078 (Lot serial: 1603716401X); Model Catalog: ORA SYSTEM 2000 (Lot serial: 1601321001X); Model Catalog: 00380659983078 (Lot serial: 1601321001X); Model Catalog: ORA SYSTEM 2000 (Lot serial: C4239R); Model Catalog: 00380659983078 (Lot serial: C4286R)
제품 설명
ORA SYSTEM 2000 INTRAOPERTIVE WAVEFRONT ABERROMETER