Z-1984-2013 Class II Terminated
FDA device recall Z-1984-2013 was initiated by Medicel Ag on August 5, 2013 and is designated Class II. 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 negat… The recall status is terminated (terminated March 11, 2014). Affected quantity: 68 boxes or 680 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2013
- Initiation Date
- August 5, 2013
- Termination Date
- March 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 boxes or 680 units
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.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Item number 37-0000-08 Lot number of the recalled products: LOT121402