Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer n

FDA device recall Z-1984-2013 · posted 2013-08-20 · Terminated

Recall details

Recalling firm

Medicel Ag

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.

Action taken

Medicel AG sent recall notification to its one direct consignee via email on 08/05/2013. The recall notification letter was titled "URGENT-Medical Device Correction Notice for nanoPOINT Injectors LOT 121402". The recall notification letter informed the customer of the product device description and lot number recalled, reason for recall, instructions to "not use this affected lot...and return them", contact information and an area on the bottom of the letter to acknowledge receipt of the correction notice. The firm's direct consignee who further distributed this product to the end users will send out notifications.

Root cause

Use error

Status

Terminated

Product code

HQL

Quantity affected

68 boxes or 680 units

Distribution

Nationwide Distribution.

Date initiated

2013-08-05

Date posted

2013-08-20

Date terminated

2014-03-11

Location

Wolfhalden, Switzerland

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