Z-1984-2013Class II

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

Name: Z-1984-2013 Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical...
Creator: Medicel Ag
Published: 2013-08-05
License: https://open.fda.gov/license/

Medicel AG / initiated 2013-08-05 / Terminated / root cause: packaging

FDA source

Medicel Ag began a recall of Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through... on 2013-08-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1984-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-05
Posted: 2013-08-20
Terminated: 2014-03-11
Recalling firm: Medicel AG
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.
Product code: HQL Intraocular Lens
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.
Root cause tag: packaging
FDA root cause: Use error
Action: 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.
Quantity in commerce: 68 boxes or 680 units
Distribution: Nationwide Distribution.
Product codes and lots: Item number 37-0000-08 Lot number of the recalled products: LOT121402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1984-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1984-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-20

Product code HQL

K070669Class IIOL Injector SetMedicel AG / cleared 2007-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)