Aid, Surgical, Viscoelastic

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2020-01-27TerminatedLabeling False and Misleading

  Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14

  Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.

• 2014-12-12TerminatedUnknown/Undetermined by firm

  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)

  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.

• 2013-12-20TerminatedNo Marketing Application

  Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

  CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspection findings of deficiencies in the Quality System Regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human

• 2010-12-16TerminatedComponent design/selection

  Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular Use REF 585304 Use as a surgical aid to protect corneal endothelium during cataract extraction procedures, intraocular lens implantation and anterior segment surgery.

  Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.

• 2008-12-10TerminatedProcess design

  AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size

  Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.

• 2005-08-23TerminatedOther

  Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA

  Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

• 2005-08-23TerminatedOther

  ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC

  Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

• 2005-08-23TerminatedOther

  Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY Product Number: 59051

  Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

• 2005-08-23TerminatedOther

  Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY Product Numbr: 59081

  Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.

• 2005-08-23TerminatedOther

  Amvisc Plus Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY Product Number: 60051

  Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.