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Recall Observatory FDA recall evidence

Device product

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.

Z-1062-2014

October 16, 2013

Class II

Product summary

Firm
Bausch & Lomb Surgical, Inc.
Event
Event 67283
Status
Terminated
Classification
Class II
Quantity
336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Official record key
device-enforcement:Z-1062-2014

Official wording

Reason: Lens was manufactured with incorrect raw material.

Code information: Model Numbers(s): AO60 and MI60L

Distribution pattern: Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lens was manufactured with incorrect raw material.