{
  "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": "Santa Ana",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69704",
      "recalling_firm": "Abbott Medical Optics Inc (AMO)",
      "address_1": "1700 E Saint Andrew Pl",
      "address_2": "N/A",
      "postal_code": "92705-4933",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (Nationwide and Puerto Rico) and internationally to the following countries; Italy, Austria, Saudi Arabia, Turkey, Hong Kong, Canada, Germany, Australia, Columbia, Venezuela, Netherlands, Portugal, New Zealand, Denmark, Argentina, France, Belgium, Costa Rica, Singapore, Ukraine, Guadeloupe, Kuwait, Chile, Peru, Mexico, Czech Republic, Serbia, Hungary, Slovenia, Guatemala, Finland, Honduras, Malaysia, United Kingdom, Spain, Switzerland, Israel, and Croatia.",
      "recall_number": "Z-0530-2015",
      "product_description": "Abbott Healon EndoCoat Ophthalmic Viscosurgical Device  3% sodium hyaluronate  0.85 mL 30 mg/mL  Sterile A Solution  Sterile EO Packaging and Cannula  Product of USA    Abbott Healon Duet Dual Pack  0.55 ml OVD  0.85 ml Healon EndoCoat OVD  Contents:   -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate)  -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate)    Part Number:  US: VT585U and 57502000 (packaged in Healon Duet 10290080)  OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)",
      "product_quantity": "484,881 Nationwide (U.S. and Puerto Rico) and 483,984 Internationally",
      "reason_for_recall": "AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.  The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.",
      "recall_initiation_date": "20141106",
      "center_classification_date": "20141208",
      "termination_date": "20150519",
      "report_date": "20141217",
      "code_info": "Part Number:  US: VT585U and 57502000 (packaged in Healon Duet 10290080)  OUS: VT585 57550500 (packaged in Healon Duet 10220010, 10220011, and 10220012)    Healon EndoCoat Device identification:  For Healon EndoCoat, each lot is assigned a unique lot number for traceability.  The lot number is a 6-digit numerical code that is equal to the manufacturing order number assigned.  The numbers 1-6 are sequentially increased representing the manufacturing order number.  Example: Lot 024992.     For Healon EndoCoat packaged in Healon Duet, each Healon Duet final product is identified witha  unique batch number.  The batch number consists of two alphabetic characters followed by five numeric characters.  The first alphabetic character of each batch number designates the manufacturing site.  The second alphabetic character of each batch number shall be sequential numbers starting with 30001.  Example: Lot UP30729 (This lot number would represent the 729th unit manufactured by AMO in 2014)."
    }
  ]
}