{ "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": "2026-04-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Fort Worth", "state": "TX", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "73777", "recalling_firm": "Alcon Research, Ltd.", "address_1": "6201 South Fwy", "address_2": "N/A", "postal_code": "76134-2099", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay", "recall_number": "Z-1694-2016", "product_description": "Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.", "product_quantity": "30,701 units", "reason_for_recall": "The product has potential to leak beyond their design specification.", "recall_initiation_date": "20150811", "center_classification_date": "20160518", "termination_date": "20170420", "report_date": "20160525", "code_info": "Lot Numbers: 1707828H 1710591H 1710852H 1710853H 1713426H 1713909H 1714519H 1714520H 1715966H 1715967H 1715968H 1715969H 1715973H 1715974H 1715975H 1715978H 1715985H 1715987H 1715990H 1715991H 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