- Nicht ganz neu, aber sehr schmerzhaft: "Advanced Medical Optics, Inc. (AMO) has issued a recall for one lot of their AMO Healon D Ophthalmic Viscosurgical Device (OVD), 30 mg/mL fill size syringes, which are intended for use during various eye surgery procedures, such as cataract surgery, secondary intraocular lens implantation, corneal transplant surgery and glaucoma filtration surgery.Testing of some OVD syringes showed endotoxin levels above the required limit, which could potentially cause eye inflammation or Toxic Anterior Segment Syndrome (TASS) in patients after surgery." (10. Dezember 2008; Quelle: FDA-Verlautbarungen)
- Schon neuer: Abbott Medical Optics is voluntarily recalling all lot numbers of Vitrax II viscoelastic solution manufactured by Lifecore Biomedical, which notified AMO that the pH of the product in some syringes was out of specification during routine stability testing. AMO says it hasn't received any complaints attributed to the pH of the product. Should the pH exceed 8.5 in a given syringe, some literature reports that endothelial cell damage may occur. (Quelle: AMO Urgent Field Safety Notice vom 27.10.2009)
- Ganz neu: "AMO has received reports that haptics of some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens optic after insertion into the eye. This situation can lead to additional manipulation to separate the haptics from the optic during surgery which could lead to an injury." (Quelle: AMO Urgent Field Safety Notice vom 09.11.2009)
Dienstag, 15. Dezember 2009
Börsen - oder Patientenwohl : Das ist hier die Frage
Abonnieren
Posts (Atom)