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Terminated

AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

FDA Recall Z-0929-2013 · Posted 2013-03-09

Recalling FirmAbbott Medical Optics Inc (AMO)
Recall StatusTerminated
Product CodeHQL
Date Initiated2012-12-20
Date Terminated2014-01-08
Product Quantity155 units

Reason for Recall

Two production orders of these IOLs that contain mislabeled IOLs.

Firm Action

AMO sent an Urgent Field Safety Notice letter to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to stop using and remove affected product from inventory. The letter advice customers to complete and return the enclosed Facsimile Form. For questions contact AMO Customer Service Representative.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.

Official Source

View FDA Recall →

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

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