{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214527", "product_res_number": "Z-2163-2025", "event_date_initiated": "2025-06-12", "event_date_posted": "2025-07-23", "recall_status": "Open, Classified", "res_event_number": "97095", "product_code": "LPL", "k_numbers": [ "K210930" ], "product_description": "ACUVUE OASYS MAX 1-Day MULTIFOCAL", "code_info": "LOT_NUMBER / PRODUCT_DESCRIPTION / UPC Number\nJ003QC7\n1D MAX MULTIFOCAL 8.4 +0.00 LOW 90P RX\n888290921027\n\nJ003QC8\n1D MAX MULTIFOCAL 8.4 +0.50 LOW 90P RX\n888290921041\n\n003QC9\n1D MAX MULTIFOCAL 8.4 +1.25 HGH 90P RX\n888290920464\nJ003QCB\n1D MAX MULTIFOCAL 8.4 +1.25 LOW 90P RX\n888290921072\nJ003QCC\n1D MAX MULTIFOCAL 8.4 +1.75 LOW 90P RX\n888290921096\nJ003QCD\n1D MAX MULTIFOCAL 8.4 +2.00 MID 90P RX\n888290921713\nJ003QCG\n1D MAX MULTIFOCAL 8.4 +2.75 MID 90P RX\n888290921744\nJ003QCH\n1D MAX MULTIFOCAL 8.4 -0.50 MID 90P RX\n888290921614\nJ003QCJ\n1D MAX MULTIFOCAL 8.4 -0.75 HGH 90P RX\n888290920389\nJ003QHP\n1D MAX MULTIFOCAL 8.4 -1.00 LOW 90P RX\n888290920983\nJ003QCK\n1D MAX MULTIFOCAL 8.4 -1.25 MID 90P RX\n888290921584\nJ003Q71\n1D MAX MULTIFOCAL 8.4 -1.75 MID 30P RX\n888290919734\nJ003Q72\n1D MAX MULTIFOCAL 8.4 -2.00 LOW 30P RX\n888290919116\nJ003Q73\n1D MAX MULTIFOCAL 8.4 -2.00 MID 30P RX\n888290919727\nJ003Q74\n1D MAX MULTIFOCAL 8.4 -2.25 LOW 30P RX\n888290919109\nJ003QHT\n1D MAX MULTIFOCAL 8.4 -2.25 LOW 90P RX\n888290920938\nJ003Q75\n1D MAX MULTIFOCAL 8.4 -2.25 MID 30P RX\n888290919710\nJ003QCL\n1D MAX MULTIFOCAL 8.4 -2.50 HGH 90P RX\n888290920389\nJ003QCM\n1D MAX MULTIFOCAL 8.4 -2.50 LOW 90P RX\n888290920921\nJ003Q76\n1D MAX MULTIFOCAL 8.4 -2.50 MID 30P RX\n888290919703\nJ003QCQ\n1D MAX MULTIFOCAL 8.4 -3.00 MID 90P RX\n888290921515\nJ003QD0\n1D MAX MULTIFOCAL 8.4 -3.50 MID 30P RX\n888290919666\nJ003QM9\n1D MAX MULTIFOCAL 8.4 -3.50 MID 90P RX\n888290921492\nJ003QD3\n1D MAX MULTIFOCAL 8.4 -4.00 LOW 30P RX\n888290919031\nJ003QD4\n1D MAX MULTIFOCAL 8.4 -4.00 MID 30P RX\n888290919642\nJ003QD5\n1D MAX MULTIFOCAL 8.4 -4.25 HGH 30P RX\n888290918416\nJ003QD9\n1D MAX MULTIFOCAL 8.4 -4.75 LOW 30P RX\n888290919000\nJ003QDG\n1D MAX MULTIFOCAL 8.4 -5.25 MID 30P RX\n888290919598\nJ003QDH\n1D MAX MULTIFOCAL 8.4 -5.50 LOW 30P RX\n888290918973\nJ003QDK\n1D MAX MULTIFOCAL 8.4 -5.75 HGH 30P RX\n888290918355\nJ003QHW\n1D MAX MULTIFOCAL 8.4 -6.50 MID 90P RX\n888290921379\nJ003QBT\n1D MAX MULTIFOCAL 8.4 -6.75 LOW 90P RX\n888290920754\nJ003QCV\n1D MAX MULTIFOCAL 8.4 -7.25 LOW 90P RX\n888290920730\nJ003QQH\n1D MAX MULTIFOCAL 8.4 -7.50 HGH 90P RX\n888290920112\nJ003QBX\n1D MAX MULTIFOCAL 8.4 -7.50 MID 90P RX\n888290921331\n\nV00D228 (J003QHT)\n1D MAX MULTIFOCAL 8.4 -2.25 LOW 5P DX\n888290922772", "firm_fei_number": "1000222023", "recalling_firm": "Johnson & Johnson Vision Care, Inc.", "address_1": "7500 Centurion Pkwy", "city": "Jacksonville", "state": "FL", "postal_code": "32256-0517", "additional_info_contact": "Global Post Market Safety Team\n800-843-2020", "reason_for_recall": "Due to defects (bubbles/voids) identified during standard finished goods testing", "root_cause_description": "Nonconforming Material/Component", "action": "On 06/12/2025, the firm sent via FedEx an \"URGENT: MEDICAL DEVICE RECALL\" letter to customers to inform them that the firm identified high density of microbubbles (microscopic voids within the contact lens) observed in specific limited lots during our quality control checks.\n\nCustomers are instructed to:\n1. Review if any of their inventory contains contact lenses impacted lot numbers.\n2. STOP using and remove from their inventory all affected product. Note: They can continue to use all other lots not affected by this voluntary recall.\n3. Pass this notice on to anyone in their organization who needs to be aware of the issue and ensure that they maintain awareness as necessary.\n4. Please contact their patients that may have received any of the affected product and ask them return for replacement.\n5. Global Post Market Safety, at 1-800-843-2020, will arrange for the return and replacement of any affected product.\n6. Complete the enclosed Customer Reply Form and return via email to vpiweb@visus.jnj.com or via fax to 904-229-0300, EVEN IF CUSTOMERS HAVE NO INVENTORY REMAINING affected by this recall. JJVC requires this information for reconciliation purposes with regulatory agencies. The completed Customer Reply Form should be emailed or faxed within 3 business days of receipt of this letter.\n\nFor questions or assistance - contact Johnson & Johnson Vision Care Global Post Market Safety, at 1-800-843-2020", "product_quantity": "114,165 lenses", "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.", "openfda": { "k_number": [ "K111345", "K984090", "K120028", "K000529", "K990011", "K242916", "K991163", "K242855", "K073485", "K132854", "K032340", "K964612", "K050717", "K050743", "K180398", "K052560", "K030167", "K181232", "K191929", "K013220", "K172692", "K161931", "K023077", "K952261", "K202129", "K043129", "K973847", "K153766", "K153642", "K962711", "K013469", "K131208", "K072777", "K994125", "K130342", "K130931", "K043540", "K233856", "K992264", "K004049", "K970312", "K020927", "K180985", "K133472", "K213216", "K162317", "K020392", "K011256", "K083288", "K033655", "K051095", "K971515", "K962804", "K990281", "K151847", "K062614", "K100244", "K142641", "K963001", "K162223", "K965052", "K011072", "K981252", "K161739", "K113168", "K942372", "K182523", "K961943", "K940777", "K964528", "K991015", "K213983", "K133079", 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