Abbott Medical Optics Inc. (AMO) recalls Healon Pro, Part No. 10270012

Recall date

April 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2066-2017

FDA classification

Class II

Brand / firm

Abbott Medical Optics Inc. (AMO)

Sold / distributed

US and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden Switzerland Tunisia Turkey Russian Fed Guadeloupe Sri Lanka Australia China Hong Kong Indonesia Malays…

Why it was recalled

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Healon Pro, Part No. 10270012