FDA Device recall Z-1984-2013
Product Name: nanoPOINT Injector System, item number 37-0000-08
- FDA Device
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of Product Name: nanoPOINT Injector System, item number 37-0000-08 by Medicel Ag, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1984-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-05 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medicel Ag |
| Distribution | US |
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.
Identifiers
| code_info | Item number 37-0000-08 Lot number of the recalled products: LOT121402 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1984-2013%22
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