FDA Devices Moderate Class II Terminated

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.

Reported: July 29, 2015 Initiated: May 26, 2015 #Z-2154-2015

Product Description

Reason for Recall

Haptics breaking during lens loading and insertion.

Details

Recalling Firm: Bausch & Lomb Surgical, Inc.
Units Affected: 72,773 units; 52,787 units (US) 19,986 units (Foreign)
Distribution: 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.
Location: Clearwater, FL

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Bausch & Lomb Surgical, Inc.. Units affected: 72,773 units; 52,787 units (US) 19,986 units (Foreign).

Why was this product recalled? ▼

Haptics breaking during lens loading and insertion.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2154-2015.