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Terminated

AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

FDA Recall Z-2274-2014 · Posted 2014-08-26

Recalling FirmAMO Puerto Rico Manufacturing, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2014-05-13
Date Terminated2017-05-18
Product Quantity77,055 IOLs in total

Reason for Recall

Units may be labeled with the incorrect diopter power.

Firm Action

AMO sent an Urgent Medical Device Recall dated May 13, 2014 to the affected customers. The letter identified the affected product, problem and actions to be taken. This recall only affects the specific Silicone Tecnis IOLs Model Z9002. Implanted IOLs with appropriate post-op refractive outcomes are not affected by this recall. Please underatake the following actions: 1. Stop using and remove from your inventory the affected product. 2.Complete and return the included Facsimile Form as AMO. If you have inventory to return, please complete the Facsimile Form, and returned to AMO. For questions contact AMO Customer Service Representative 877-266-4543.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign: Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.

Official Source

View FDA Recall →

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

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