FDAFDA · Food and drugs·Recall number Z-1062-2014
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Published February 26, 2014 · Recall initiated: October 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lens was manufactured with incorrect raw material.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
- Lot
- Model Numbers(s): AO60 and MI60L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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