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U.S. Department of Health and Human Services

Class 2 Device Recall nanoPOINT Injector System

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  Class 2 Device Recall nanoPOINT Injector System see related information
Date Initiated by Firm August 05, 2013
Date Posted August 20, 2013
Recall Status1 Terminated 3 on March 11, 2014
Recall Number Z-1984-2013
Recall Event ID 65908
510(K)Number K070669  
Product Classification intraocular lens - Product Code HQL
Product 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.

Code Information Item number 37-0000-08  Lot number of the recalled products: LOT121402
Recalling Firm/
Manufacturer
Medicel Ag
Luchton 1262
Wolfhalden Switzerland
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Use error
Action 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.
Quantity in Commerce 68 boxes or 680 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQL and Original Applicant = MEDICEL AG
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