November 22, 2019

Singapore Warns of Trace Compounds in Glaucoma Implants

Singapore’s Health Services Agency issued an alert on a recall of all lots of Allergan XEN glaucoma treatment system due to the presence of residual compounds from the manufacturing process.

The system is comprised of the XEN 45 gel stent preloaded into a XEN injector that is permanently implanted into the eye. The implant is designed to lower eye pressure in patients with refractory glaucoma where previous surgical treatment failed or medications alone were not sufficient.

During an in-process inspection, four units in an unreleased XEN 45 lot were observed to have trace amounts of residual polishing compounds used in the needle sleeve manufacturing process, Allergan said.

Allergan later recalled 15 lots of the implants, and healthcare professionals were advised to stop using the devices as foreign particles on the needle assembly could be transferred to the patient’s eye during the procedure.

Allergan said that foreign particles in the eye could result in irritation, inflammation, local allergic reaction, hypersensitivity, iritis/iridocyclitis or uveitis/sterile endophthalmitis.

It warned that removal of an implanted XEN device is not recommended, and physicians should continue the standard of care post-operative follow up regime for XEN surgery.

Switzerland to Mirror EU MDR For Combination Products

The Swiss agency for therapeutic products said it will follow the EU’s Medical Device Regulation for combination products.

Applications for an integral device combination product that lacks certification from a conformity assessment body must demonstrate that the device component satisfies requirements under Annex 1 of the EU MDR 93/42/EEC, the agency said.

Swissmedic said it will follow the revised provisions under the new EU MDR once the regulations become effective in May 2020. Under the new regulation, a notified body opinion must be submitted with applications for integral device components.

TGA Flags Risks for Accu-Chek Blood Glucose Meters

Australia’s Therapeutic Goods Administration announced product defects in the Accu-Chek Guide and Accu-Chek Performa blood glucose meters that could cause a delay in therapy.

Accu-Chek Guides with serial numbers lower than 92911000001 and Performa meters with serial numbers between 68920000000 and 68925525056 may display battery replacement indications, unexpectedly show the low battery icon, have short battery life and fail to turn on, the agency warned.

The errors could lead to serious medical issues for diabetic patients if therapy decisions are hindered by the device defects, the agency said.