FDA-Device2013-08-28Class II
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.
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.
Sold states
Nationwide Distribution.
Affected count
68 boxes or 680 units
Manufactured in
Luchton 1262, N/A, Wolfhalden, N/A, Switzerland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1984-2013Don't want to check this manually?
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