Device & Drug Alerts
All alerts are avilable on the MHRA Ophthalmic websiteDevice: Intraocular lens (IOL) - hydrophilic acrylic issued 21 January 2010
(Added 8 March 2010)
Problem: Opacification of IOLs may occur following intracameral use of altepase (recombinant tissue plasminogen activator, r-tPA).
Action:
- Ensure all relevant staff are made aware of this issue.
- Report all IOL opacification incidents to the MHRA
Device: Staining solution for ophthalmic surgery
(3 March 2009)
Problem: The plunger may stick within the barrel of the syringe. This has led to the use of excessive force during injection of the solution, resulting in a sudden jet of liquid that can cause serious damage to intraocular tissues.
Action:
- Identify if you have any of these devices.
- As part of your pre-use checks ensure that the plunger moves smoothly within the barrel of the syringe by pulling back the plunger prior to priming and injecting the solution.
Contact:
Manufacturer: Peter Karels, Quality Assurance & Regulatory Affairs Manager, DORC International BV
Tel: +31 (0) 181 45 80 80
E-mail: QA@dorc.nl
Device: Disposable pen torch manufactured by Merlin Medical Ltd and distributed by Williams Medical Supplies.
(21 April 2008)Model Number: W2137
NHS Supply Chain Reference (England only): FFE066
Problem: Incorrect bulb placement due to a manufacturing fault which can cause the bulb to explode upon illumination or be damanged during normal use.
Action:
- Identify and isolate all pen torches with the bulb protuding more than 1.5mm beyond the tip of the torch
- Contact the supplier to arrange for any affected product to be replaced with updated stock
- Ensure all users are aware of the updated information card which states that the pen torch should be tested away from the patient before use
Page Updated: 11 March 2010 (BB)