{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "169043", "product_res_number": "Z-0628-2019", "event_date_initiated": "2018-11-05", "event_date_created": "2018-12-18", "recall_status": "Terminated", "event_date_terminated": "2019-11-04", "res_event_number": "81600", "product_code": "HQL", "pma_numbers": [ "P910056" ], "product_description": "enVista One Piece Hydrophobic Acrylic Intraocular lens - \n\nIs indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.", "code_info": "Model MX60E and specific lots of the following SKU's: MXUE0000, MXUE0100, MXUE0200, MXUE0300, MXUE0400, MXUE0500, MXUE0600, MXUE0700, MXUE0800, MXUE0900, MXUE1000, MXUE1050, MXUE1100, MXUE1150, MXUE1200, MXUE1250, MXUE1300, MXUE1350, MXUE1400, MXUE1450, MXUE1500, MXUE1550, MXUE1600, MXUE1650, MXUE1700, MXUE1750, MXUE1800, MXUE1850, MXUE1900, MXUE1950, MXUE2000, MXUE2050, MXUE2100, MXUE2150, MXUE2200, MXUE2250, MXUE2300, MXUE2350, MXUE2400, MXUE2450, MXUE2500, MXUE2550, MXUE2600, MXUE2650, MXUE2700, MXUE2750, MXUE2800, MXUE2850, MXUE2900, MXUE2950, MXUE3000, MXUE3100, MXUE3200, MXUE3300, and MXUE3400.", "firm_fei_number": "1119279", "recalling_firm": "Bausch & Lomb Surgical, Inc.", "address_1": "21 N Park Place Blvd", "city": "Clearwater", "state": "FL", "postal_code": "33759-3917", "additional_info_contact": "727-724-6600", "reason_for_recall": "Cosmetic imperfections on the surface of some lenses.", "root_cause_description": "Process control", "action": "On Nov 5, 2018 Bausch & Lomb sent letters to all their consignees, requesting the following;\n1. Review and quarantine your inventory of all the impacted lots for this recall.\n2. Complete the enclosed Medical Device Voluntary Recall Acknowledgement Form and contact B&L to obtain a return material authorization number and arrange for a pick up of the identified product. Contact 800-338-2020 option 2.\n\nIf you have any questions, contact the Quality Manager at 727-724-6695.", "product_quantity": "70,440 units", "distribution_pattern": "US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.", "openfda": { "k_number": [ "K842892", "K914311", "K842504", "K913626", "K771933" ], "pma_number": [ "P990013", "P990080", "P910056", "P870073", "P960036", "P820035", "P830033", "P830040", "P910061", "P880072", "P820072", "P810001", "P930014", "P910060", "P860002", "P900048", "P840050", "P850059", "P900037", "P880087", "P880070", "P820044", "P080004", "P090022", "P880090", "P890056", "P910058", "P790027", "P810032", "P810056", "P810042", "P840033", "P900053", "P870013", "P060022", "P990014", "P190018", "P060011", "P800049", "P880091", "P890068", "P870075", "P840039", "P870045", "P800016", "P830056", "P800017", "P940007", "P880010", "P810055", "P240038", "P860034", "P800027", "P880082", "P080021", "P980040", "P840060", "P970034", "P860059", "P820016", "P820049", "P880081", "P880085", "P810018", "P040020", "P100016", "P010027", "P960034" ], "registration_number": [ "9681630", "3015456951", "3013202565", "3007530141", "1063199", "2011171", "3024715547", "9613160", "1054811", "3012304651", "9614546", "3017435679", "2438659", "3006946276", "1037089", "2031959", "3008344633", "3002807314", "2648035", "2031928", "1281950", "2032098", "3020977988", "1064514", "2031474", "2246552", "3010126268", "1211998", "1048735", "3010148516", "2029275", "3010155661", "1313525", "1610287", "9614429", "2953359", "2529709", "2023826", "9681121", "3006723646", "1119279", "9612169", "3007207818", "3007125265", "3017636737", "3014173684", "1119421", "3012236936", "3003304724", "2020277", "3014002883", "2030624", "3010413216", "3008641313", "3008449456", "9710098", "1038833" ], "fei_number": [ "3002957101", "3015456951", "3013202565", "3007530141", "2011171", "3024715547", "1000306431", "3012304651", "3003058448", "3017435679", "3006946276", "1037089", "1000121259", "3002808259", "3008344633", "3000215205", "3002807314", "2648035", "3002777043", "3002936283", "1281950", "3020977988", "3002807944", "2246552", "3010126268", "1211998", "1048735", "3010148516", "1000114185", "3010155661", "1610287", "3001284430", "3002023310", "2023826", "3003088462", "3006723646", "3002808845", "1119279", "3007207818", "3004161528", "3007125265", "3017636737", "3014173684", "3001659659", "1317628", "3012236936", "1119421", "3003304724", "2020277", "3002808262", "3014002883", "3010413216", "3008641313", "3008449456", "3000206435", "3004651700", "1038833" ], "device_name": "Intraocular Lens", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.3600", "device_class": "3" } } ] }