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.
FDA Recall Z-2154-2015 · Posted 2015-07-20
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Recalling FirmBausch & Lomb Surgical, Inc.
Recall StatusTerminated
Product CodeHQL
Date Initiated2015-05-26
Date Terminated2016-08-25
Product Quantity72,773 units; 52,787 units (US) 19,986 units (Foreign)
Reason for Recall
Haptics breaking during lens loading and insertion.
Firm Action
Bausch + Lomb sent an Urgent Medical Device Recall letter dated May 29, 2015 to their custometers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: segregate the identified IOLs, return the IOLs through your B&L representative or by using the prepaid shipping label included in this package, order replacement product through customer service (800) 338-2020 or your B&L representative and complete & return the acknowledgement form included in this package. Customers were advised that if replacement product is needed for a scheduled surgery before your full return can be processed, please contact your B&L representative to expedite shipment of the IOL. For questions contact Bausch + Lomb at (800) 338-2020.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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