Z-1964-2016Class II

STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses

Name: Z-1964-2016 STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses
Creator: Staar Surgical Co.
Published: 2016-05-02
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2016-05-02 / Terminated / root cause: manufacturing process

FDA source

Staar Surgical Co. began a recall of STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses on 2016-05-02. FDA classified it as Class II and gives the reason as "The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1964-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Posted: 2016-06-14
Terminated: 2016-11-15
Recalling firm: Staar Surgical AG
Product: STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Product code: KYB Lens, Guide, Intraocular
Reason for recall: The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: STAAR sent a Medical Device Recall Letter dated May 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STAAR Surgical is recalling the STAAR AQ Cartridge-FP because it may malfunction and may crack during loading or delivery of the IOL. Customers with questions are instructed to contact their STAAR customer service representative at (800) 352-7842.
Quantity in commerce: 2,612 units
Distribution: US
Product codes and lots: 1281706, 1282812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1964-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1964-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-14

Product code KYB

K940593Class IDisposable Microstaar InjectorStaar Sugical / cleared 1994-09-19

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)