Alcon Research, Ltd.: Medical Device Recall in 2016 - (Recall #: Z-1597-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.

Product Classification:

Class II

Date Initiated: October 6, 2014

Date Posted: May 11, 2016

Recall Number: Z-1597-2016

Event ID: 73767

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.

Status: Terminated

Product Quantity: 6597 packs

Code Information:

Lot numbers: 1623139H, 1623140H, 1623138H, 1623141H, 1623765H, 1623148H, 1623766H, 1623767H, 1623768H, 1623142H

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated