Class II — Medicel Ag
| Recalling firm | MEDICEL AG |
|---|---|
| Registered facility | MEDICEL AG (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 68 boxes or 680 units |
| Distribution | Nationwide Distribution. |
| Initiated | 2013-08-05 |
| Classified | 2013-08-20 |
| Terminated | 2014-03-11 |
| Recall number | Z-1984-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medicel Ag (Z-1984-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65908/
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