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)
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.
Action Details
Abbott Medical Optics issued an Urgent Advisory Notice dated November 4, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to consult the DFU that is distributed with each device, which contains important warning and precautions for use of the product. Customers were instructed to provide a copy of the Advisory Notice to surgeons and thsoe who need to be aware in their organization. Custommers with questions were instructed to call 877-266-4543.
For questions regarding this recall call 714-247-8656.
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.
Code Information / Serial Numbers
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).