Z-1597-2016Class II

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721...

Name: Z-1597-2016 INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721...
Creator: Alcon Research, Ltd.
Published: 2014-10-06
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2014-10-06 / Terminated

FDA source

Alcon Research, Ltd. began a recall of INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated... on 2014-10-06. FDA classified it as Class II and gives the reason as "The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1597-2016
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2016-05-03
Terminated: 2017-03-31
Recalling firm: Alcon Laboratories
Product: INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Product code: HQC Unit, Phacofragmentation
Reason for recall: The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
FDA root cause: Process change control
Action: The recalling firm notified affected customers on 10/6/2014 via a customer letter with an attached Medical Device Removal Response Form. On 10/23/2014, a second notification was sent to 76 customers who did not respond to the initial notification.
Quantity in commerce: 6597 packs
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1597-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1597-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03

Product code HQC

K021566Class IIInfinitiAlcon Laboratories, Inc. / cleared 2002-07-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)