{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Clearwater", "state": "FL", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "71411", "recalling_firm": "Bausch & Lomb Surgical, Inc.", "address_1": "21 N Park Place Blvd", "address_2": "N/A", "postal_code": "33759-3917", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit", "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.", "recall_number": "Z-2154-2015", "product_description": "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.", "product_quantity": "72,773 units; 52,787 units (US) 19,986 units (Foreign)", "reason_for_recall": "Haptics breaking during lens loading and insertion.", "recall_initiation_date": "20150526", "center_classification_date": "20150720", "termination_date": "20160825", "report_date": "20150729", "code_info": "Produce Code: LI61AO and LI61SE. 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