12/23/2020 · 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
4/1/2017 · Healon GV , Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014: Code Information: UB32596, UB32571, UB32597, UB32577, UB32576: Recalling Firm/ Manufacturer: Abbott Medical Optics Inc. (AMO) 1700 E Saint Andrew Pl Santa Ana CA 92705-4933: For Additional Information Contact: 714-247-8200 Manufacturer Reason for Recall, HEALON GV ® Pro offers high viscosity for deep anterior chamber creation and maximum space for maneuverability with minimal damage to the cornea or other delicate ocular tissues. Compared to other OVDs, the HEALON GV ® produced considerably less endothelial cell loss. SPECIFICATIONS: Classification: Cohesive Product Volume: 0.85 ml Viscosity: 2.60 – 3.50 Log (Pas) Composition: 1.8%.
Approval For Healon GV ® PRO, A Modification Of The Healon5 PRO OVD With The Sodium Hyaluronate Concentration Changed From 23 Mg/mL To 18 Mg/mL. The Device, As Modified, Will Be Marketed Under The Trade Name Sodium Hyaluronate Ophthalmic Viscoelastc Device (OVD), Healon GV ® PRO And Is Indicated For Use In Anterior Segment Ophthalmic Surgical Procedures Of The.
Healon GV ® Sodium Hyaluronate 14 mg / mL Intraocular Injection Prefilled Syringe 0.85 mL Abbott Medical Optics 05047450854, List of Medical Device recalls in 2020. The .gov means it’s official. Federal government websites often end in .gov or .mil.
Healon GV (sodium hyaluronate 1.4%, AMO, Advanced Medical Optics, Santa Ana, Calif.) is an alternative to this, but people can more easily develop higher IOP thereafter. “It’s unforgiving in that regard,” Dr. Packer said. So, Dr. Packer continued his search for an OVD. He wanted something that was easy to remove but still stay in the eye …
INDICATIONS AND IMPORTANT SAFETY INFORMATION for HEALON ® PRO Ophthalmic Viscoelastic Device (OVD). Rx Only. INDICATIONS. The HEALON ® PRO OVD is indicated for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery.. In surgical procedures in the anterior segment of the eye …
4/1/2009 · Healon is cohesive while Healon GV is even more cohesive, with the GV standing for greater viscosity. Combination OVDs. For routine cases, much effort has been put into making a single agent with both dispersive and cohesive properties. This is a challenge since it is difficult to provide the full spectrum of properties with a single agent.
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