Reported Dec 17, 2014 · Terminated
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution…
Abbott Medical Optics Inc. (AMO)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical Optics Inc (AMO) · 1700 E Saint Andrew Pl · Santa Ana, CA · 92705-4933
Is this the product you have?
- 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 NumberUS: VT585U and 57502000 (packaged
- in Healon Duet 10290080) OUSVT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 lot number for traceability. The 2 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 3 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 4 Lot UP30729 (This 5 lot number would represent the 729th unit manufactured by AMO in 2014). - Amount recalled
- 484,881 Nationwide (U.S. and Puerto Rico) and 483,984 Internationally
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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