Alcon CyPass Micro-Stent 의 안전성 경고

Safety alert

2018-08-29

2018-08-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180829c.html

Medical device safety alert: alcon cypass micro-stent medical device manufacturer, alcon, has issued a medical device safety alert concerning its cypass micro-stent. the locally affected devices are identified as follow: model number: 241 (8065754001) lot number: fg122017005, fg112017003 & fg112017005 the manufacturer is conducting a voluntary field safety corrective action (withdrawal) of all versions of the cypass micro-stent. the stent is indicated for use in the reduction of intraocular pressure in adult patients with mild to moderate primary open-angle glaucoma (poag). the two-year compass study, which served as a basis for regulatory approvals of the cypass micro-stent for use in conjunction with cataract surgery, included an evaluation of endothelial cell loss (ecl). at two years post-surgery there was little difference in ecl between the cypass micro-stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related ecl. the compass-xt study was designed to collect safety data on the subjects who participated in the compass study for an additional three years, with analysis of the completed data set at five years post-surgery. at five years, the cypass micro-stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. a healthy corneal endothelium is responsible for corneal clarity, which is necessary for good vision. endothelial cells do not replicate, and when they are traumatized they are permanently lost. when the number of cells remaining goes below a critical threshold corneal edema (swelling) ensues. corneal decompensation frequently follows, leading to loss of corneal clarity and a subsequent decline in vision. treatment to regain corneal clarity often requires a corneal transplant. based on information currently available, surgeons should consider the following recommendations for evaluating and managing patients who have been implanted with the cypass micro-stent: the manufacturer recommends that all patients who have been implanted with a cypass micro-stent undergo post-operative gonioscopy (if not performed previously) to assess stent position, and periodic assessments of endothelial cell density using specular microscopy; surgeons who are considering stent adjustment or removal should review the information in the cypass micro-stent instructions for use (ifu). healing response and progressive engagement of implant retention features must be factored into the decision to remove the cypass micro-stent after the immediate postoperative period (i.E., after 1 month postoperative). surgeons should consider less invasive intervention such as positional adjustment or trimming of the cypass micro-stent proximal end as a first alternative to device removal. it is highly recommended that surgeons consult the manufacturer prior to device removal; after the immediate postoperative period, trimming of the proximal end of the cypass micro-stent may be considered when the anterior position of the stent appears likely to compromise corneal endothelial health. there is limited clinical data on the effects trimming may have on ecl. surgeons should consider the risks of further endothelial cell trauma caused by the trimming procedure against the potential benefits of the procedure. a procedure for stent trimming is set out in the ifu. in addition, the manufacturer advises surgeons to immediately cease implanting the cypass micro-stent. affected users should quarantine any unused products and product removal is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 29 august 2018.