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Terminated

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.

FDA Recall Z-1123-2014 · Posted 2014-03-03

Recalling FirmAMO Puerto Rico Manufacturing, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2014-01-28
Date Terminated2017-04-19
Product Quantity169 units

Reason for Recall

Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.

Firm Action

Beginning on January 28, 2014, AMO began distribution of the Recall Notification Letter to the 72 AMO TECNIS IOL customer accounts within the United States who had received lenses from the 2 affected P/O's. 100% delivery of the recall communication to US customers was confirmed on January 31, 2014. Included with the Recall Notification Letter is a facsimile delivery confirmation which each customer is instructed to fax back to AMO.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Great Britain, Canada and Japan.

Official Source

View FDA Recall →

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

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