Medical device recalls Moderate risk

Bausch & Lomb Surgical, Inc. recalls Bausch & Lomb SofPort Advanced Optics Aspheric Lens

Recall date
May 26, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2153-2015
FDA classification
Class II
Brand / firm
Bausch & Lomb Surgical, Inc.
Sold / distributed
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, Hawaii and Puerto Rico and countries of: Canada, Brazil, Argentina, Austria, Belgiu…

Why it was recalled

Haptics breaking during lens loading and insertion.

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

What was recalled

Bausch & Lomb SofPort Advanced Optics Aspheric Lens

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