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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description 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.
Recall Number Z-1984-2013
Classification Class II
Code Info Item number 37-0000-08 Lot number of the recalled products: LOT121402
Product Distributed Qty 68 boxes or 680 units
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.

Event Detail

Event Id 65908
Product Type Devices
Status Ongoing
Recalling Firm Medicel Ag
City Wolfhalden
State
Country CH
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-05
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution.
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