Device Recall Healon EndoCoat Ophthalmic Viscosurgical Device and Healon Duet Dual Pack

  • Modèle / numéro de série
    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).
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    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.
  • Description du dispositif
    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)
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Abbott Medical Optics Inc (AMO), 1700 E Saint Andrew Pl, Santa Ana CA 92705-4933
  • Société-mère du fabricant (2017)
  • Source