CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report

Staar AQ Cartridge-FP, guide and delivery system recalled

Staar Surgical is recalling Staar AQ Cartridge-FP, guide and delivery system for Intraocular lenses. The recall was initiated on 2 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1281706, 1282812

Quantity recalled2,612 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1964-2016
FDA event ID: 74067
Recalling firm: Staar Surgical, Monrovia, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 May 2016
FDA classified: 14 Jun 2016
Reported: 22 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Contact Lenses & Eye Devices

Timeline

2 May 2016	Recall initiated by company
14 Jun 2016	Classified by FDA	+43 days
22 Jun 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Questions about this recall

Why was it recalled?

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

Which lots are affected?

1281706, 1282812

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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