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Terminated

LAUREATE World Phaco System

FDA Recall Z-2834-2016 · Posted 2016-09-15

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHQC
Date Initiated2016-07-28
Date Terminated2017-06-07
Product Quantity8,646 UNITS

Reason for Recall

Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)

Firm Action

All remaining inventory of the identified affected products within Alcon DCs will be supplied corrected directions for use material prior to any further shipments.

Root Cause

Labeling Change Control

Distribution Pattern

Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021566INFINITIAlcon Laboratories, Inc. · 2002-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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