Medicel Ag: Medical Device Recall in 2013 - (Recall #: Z-1984-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class II

Date Initiated: August 5, 2013
Date Posted: August 28, 2013
Recall Number: Z-1984-2013
Event ID: 65908
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.

Status: Terminated
Product Quantity: 68 boxes or 680 units
Code Information:

Item number 37-0000-08 Lot number of the recalled products: LOT121402

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated