Recall Z-1984-2013— Medicel Ag
Class II · Terminated
Class II FDA medical device recall by Medicel Ag, initiated 2013-08-05, terminated 2014-03-11. It names one FDA 510(k) clearance: K070669. 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.. 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..
- Recalling firm
- Medicel Ag
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-05
- Terminated
- 2014-03-11
- Firm location
- Wolfhalden, N/A, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.