EU postmarket surveillance plans for medical devices.

Purpose: Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan.

Evaluation of an integrated orbital tissue expander in congenital anophthalmos: report of preliminary clinical experience.

Purpose: To evaluate the effectiveness of an orbital tissue expander designed to stimulate orbital bone growth in an anophthalmic socket.

Design: Retrospective, noncomparative, interventional case series.

Settings: Institutional.

Estimation of intraocular pressure in rabbits with commonly used tonometers.

Background And Objectives: To validate accuracy and reproducibility of the Perkins tonometer, pneumatonometer, and Tono-Pen XL (Medtronic Solan, Jacksonville, FL) in estimating intraocular pressure (IOP) in rabbits.

Materials And Methods: IOP was increased from 5 to 50 mm Hg in 5-mm increments. Measurements were compared to readings of two digital manometers simultaneously measuring real IOP in the anterior chamber and vitreous cavity.

A newly designed glaucoma drainage implant made of poly(styrene-b-isobutylene-b-styrene): biocompatibility and function in normal rabbit eyes.

Objective: To report clinical evaluation, flow patency, and histopathological findings of a novel glaucoma drainage implant (GDI) made of poly(styrene-b-isobutylene-b-styrene) (SIBS) in rabbits.

Methods: In 16 normal eyes, the proximal end of the SIBS GDI was inserted into the anterior chamber while the distal end was placed in the subconjunctival space. A control group underwent implantation of a similarly designed silicone GDI.

Validation of the Barraquer tonometer for high intraocular pressure estimation.

Purpose: To compare the pneumatonometer and the Tono-Pen XL in a closed ex-vivo system in human eye bank eyes at high intraocular pressures (IOP) and evaluate the validity of high IOP measurements with the Barraquer tonometer.

Methods: Intraocular pressure was monitored by cannulation of the anterior chamber and vitreous cavity in eight human cadaver eyes (mean donor age: 77.3 +/- 4.

Efficacy of various drugs in the prevention of posterior capsule opacification: experimental study of rabbit eyes.

Purpose: To assess the efficacy of various drugs in the prevention of posterior capsule opacification (PCO) in a closed capsular bag technique.

Setting: Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida, USA.

Methods: Lens material was removed using phacoaspiration or phacoemulsification through a microcapsulorhexis according to the hardness of the crystalline lens correlated with the weight and age of the rabbits.