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Medicel Ag recalls Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collame
Recalled August 28, 2013 · FDA recall Z-1984-2013 · Medicel Ag
Hazard
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. · FDA Class II
Units
68 boxes or 680 units
Sold at
Nationwide Distribution.
Description
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.
Manufacturer(s)
Medicel Ag
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →