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Bausch & Lomb Surgical, Inc. recalls Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary im
Recalled July 29, 2015 · FDA recall Z-2154-2015 · Bausch & Lomb Surgical
Hazard
Haptics breaking during lens loading and insertion. · FDA Class II
Units
72,773 units; 52,787 units (US) 19,986 units (Foreign)
Sold at
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, Belgium, Switzerland, Germany, Spain, France, Great Britain, Georgia, Greece, Kyrgyzstan, Norway, Russia, Ukraine, United Arab Emirates, China, Australia, India Malaysia, Korea, and Taiwan.
Description
Haptics breaking during lens loading and insertion.
Product
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are 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.
Manufacturer(s)
Bausch & Lomb Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →