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Terminated

AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses

FDA Recall Z-0148-2007 · Posted 2006-12-14

Recalling FirmAdvanced Medical Optics, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2006-11-29
Date Terminated2011-05-24
Product Quantity10 lenses

Reason for Recall

The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.

Firm Action

On November 13, 2006, an 'URGENT MEDICAL DEVICE RECALL' letter was mailed to all affected US customers communicating their recall strategy regarding the removal of five (5) ZA9003 lenses in US distribution. This letter included in this correspondence is a listing of the serial numbers and the quantities of intraocular lenses shipped. This listing will act as your Facsimile Form to be returned to AMO for accountability of the lenses shipped to your facility. AMO will ensure the effectiveness of the recall by using a return facsimile form to capture the status of each of the lenses.

Root Cause

Other

Distribution Pattern

Worldwide, including USA (CT, TX, NY), Canada, and UK.

Official Source

View FDA Recall →

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

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