Device 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.
Z-1984-2013
Product summary
- Firm
- Medicel Ag
- Event
- Event 65908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 boxes or 680 units
- Official record key
device-enforcement:Z-1984-2013
Official wording
Reason: 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.
Code information: Item number 37-0000-08 Lot number of the recalled products: LOT121402
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.