Product Name: nanoPOINT Injector System — Class II medical device recall Z-1984-2013
Terminated recall by Medicel Ag, reported 2013-08-28, distributed nationwide. The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids m
| Recall number | Z-1984-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicel Ag, Wolfhalden, N/A, Switzerland |
| Recall initiated | 2013-08-05 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-03-11 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, specification failure |
| Lot numbers | 121402 |
| Model numbers | 37-0000-08 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1984-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.