U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
intraocular lens - Product Code HQL
원인
The firm initiated this recall of one lot (121402) of nanopoint injectors after they noticed that tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.
조치
Medicel AG sent recall notification to its one direct consignee via email on 08/05/2013. The recall notification letter was titled "URGENT-Medical Device Correction Notice for nanoPOINT Injectors LOT 121402". The recall notification letter informed the customer of the product device description and lot number recalled, reason for recall, instructions to "not use this affected lot...and return them", contact information and an area on the bottom of the letter to acknowledge receipt of the correction notice.
The firm's direct consignee who further distributed this product to the end users will send out notifications.
Product Name: nanoPOINT Injector System, item number 37-0000-08. || Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.