Distilled water and 10 mM EDTA treatments were the most efficient in retarding the appearance of PCO.

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. Methods This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow‐up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices. Results The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. Conclusions The PMS plan may serve as a thorough tool for the benefit‐risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.

<H4>BACKGROUND AND OBJECTIVES</H4> <P>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. </P> <H4>MATERIALS AND METHODS</H4> <P> 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. Interobserver accuracy was evaluated using 4 eyes with the Perkins tonometer. </P> <H4>RESULTS</H4> <P> The Perkins tonometer and Tono-Pen XL underestimated IOP and were more accurate at pressures less than 30 mm Hg. No statistically significant difference was found between real IOP and Tono-Pen XL readings. The pneumatonometer overestimated pressures in the low ranges but was accurate at pressures greater than 40 mm Hg. The Tono-Pen XL had more variability than the Perkins tonometer and pneumatonometer at high IOP. </P> <H4>CONCLUSIONS</H4> <P> None of the tonometers are accurate or reproducible in estimating IOP in rabbits over the tested range. Pneumatonometry, although not very accurate, has the advantage of having acceptable variability. </P> <P>[<CITE>Ophthalmic Surg Lasers Imaging</CITE> 2007;38:43-49.] </P> <H4>AUTHORS</H4> <P>From the Ophthalmic Biophysics Center (ACA, EME, IN, MO, HY, FF, J-MP), Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; the Biostatistic Center (ASV), Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida; the Department of Biomedical Engineering (J-MP), University of Miami College of Engineering, Miami, Florida; and the University of Liege (J-MP), Liege, Belgium. </P> <P>Accepted for publication September 18, 2006. </P> <P>Supported by Florida Lions Eye Bank; InnFocus LLC, NIH Center Grant No. P30-EY014801, Research to Prevent Blindness, Inc.; and the Henri and Flore Lesieur Foundation. </P> <P>Address correspondence to Jean-Marie Parel, PhD, Ophthalmic Biophysics Center, Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, 1638 NW 10th Avenue, Miami, FL 33136. </P>