Recall Z-1984-2013 ยท HQL Intraocular Lens
Medicel Ag
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.
| Date | Aug 20, 2013 (initiated Aug 5, 2013) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 68 boxes or 680 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070669 | IOL INJECTOR SET Medicel AG, Nov 1, 2007 |