{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192932", "product_res_number": "Z-1007-2022", "event_date_initiated": "2022-03-16", "event_date_created": "2022-04-26", "recall_status": "Open, Classified", "res_event_number": "89928", "product_code": "HNQ", "product_description": "ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.", "code_info": "Model: 303071-9090-000\nCatalog Number: FG-50608\nUDI: (01)04049539104496(11)201102(17)231031(10)FG21082410\nLot Number: FG21082410", "firm_fei_number": "3003481798", "recalling_firm": "Carl Zeiss Meditec AG", "address_1": "Rudolf-Eber-Str. 11 11 rudolf-eber-str.", "city": "Oberkochen", "country": "Germany", "additional_info_contact": "Scott Smith\n704-906-3287", "reason_for_recall": "High friction of the slider can cause the device to stick, or not move as intended.", "root_cause_description": "Under Investigation by firm", "action": "On 03/16/2022, the Recalling firm called U.S. Customers to inform them of that is has been determined that single lot (Lot FG21082410) of the ZEISS miLoop may have been provided with potentially too high friction of the slider. A follow-up email was sent on 03/22/2022 that contained an \"Urgent Medical Device Recall\" letter.\n\nCustomer are asked to discontinue the use and not to further distribute the specific product lot, and to fill out the attached acknowledgement form to dl.med-qualitycti.us@zeiss.com. Customer are asked to return all devices from lot FG21082410 to Carl Zeiss Meditec AG. \n\nFor question or assistance, contact:\nScott Smith, Director of Sales at (704) 906-3287 or email scott.smith@zeiss.com", "product_quantity": "1225 devices", "distribution_pattern": "U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV\n\nO.U.S.: Not provided", "openfda": { "k_number": [ "K791985", "K022842", "K801469", "K874991", "K770103", "K770098", "K863988", "K030471", "K864292", "K870440" ], "registration_number": [ "1057946", "", "3003435550", "9615745", "3006677911", "3022862651", "3013938829", "3007589160", "8040278", "3013002167", "3029990829", "3006380247", "3000264417", "3003860763", "9615659", "9611502", "3009732568", "3010383847", "3008618183", "3002675176", "8044098", "3009027787", "9611503", "2242450", "3003972428", "3010155661", "1036836", "3005528784", "3015895045", "9612297", "2248180", "3012448339", "3012123033", "3014615697", "3030446844", "3008808084", "3035678069", "9617768", "3033485955", "3008936260", "1926681", "3015456951", "9614107", "3013497507", "1412854", "1836161", "3003860739", "3006234591", "3010487482", "3005067367", "1424263", "2916714", "3007597038", "1646747", "3017970077", "3008338766", "3005809810", "8043467", "8010694", "8010851", "1421879", "1054811", 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