Abbott Medical Optics Inc (AMO): 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)

Recall number

Z-0530-2015

Recalling firm

Abbott Medical Optics Inc (AMO)

Product

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)

Status

Terminated

Initiated

2014-11-06

Posted

2014-12-12

Terminated

2015-05-19

Reason

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.

Root cause

Unknown/Undetermined by firm

Action

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.

Quantity

484,881 Nationwide (U.S. and Puerto Rico) and 483,984 Internationally

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.

Lot, serial or model codes

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).

510(k) numbers

not on file

PMA numbers

["P110007","P810031"]

Product code

LZP

Firm FEI

3003843509

Firm city

Santa Ana

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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