Reported Aug 28, 2013 · Terminated
Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿…
Medicel Ag
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medicel Ag · Luchton 1262 · Wolfhalden, N/A · N/A
Is this the product you have?
- Product NamenanoPOINT 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
- Lot codes and dates
- Item number 37-0000-08
- Lot number of the recalled productsLOT121402
- Amount recalled
- 68 boxes or 680 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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