Recent alerts
Opioids prescribed as part of a drug maintenance programme (eg. Methadone) have been widely associated with visual pathology in children exposed in utero, as well as with MRI brain changes in volume and myelination. Foetal Opioid Spectrum Disorder includes nystagmus, squint, refractive error, impaired smooth pursuit, reduced visual acuity and poor binocular vision.
Recently we have become aware in Scotland, of cases of Foetal Opioid Spectrum Disorder in children exposed to opioids prescribed for pain relief in pregnancy (eg. Tramadol, Dihydrocodeine and Morphine), given for back pain or pelvic girdle pain for instance. These include children with long-term nystagmus. The SPROGS group have informed the Chief Medical Officer’s office (Scotland) and are currently submitting Yellow Cards to MHRA. A policy change to ensure that all women of child-bearing age prescribed an opioid have a warning of potential visual effects is indicated and efforts to ensure this are being made.
Please consider submitting a Yellow Card for suspected cases.
A series of batches of Dutch Ophthalmic Research Center (DORC) directional laser probes has been identified as being faulty and posing a potential risk to patient safety. The impacted product codes are 7220.xxx, 7223.xxx, 7225.xxx and 7227.xxx, where xxx can be ALC, DORC, or IRI. A field safety notice (FSN) has been released.
As of 21 March 2024, UKHSA, MHRA and the College are satisfied that the risk associated with this outbreak has reduced such that there is no longer need to avoid use of carbomer-containing lubricating eye products. Therefore, the recommendation to avoid use of all carbomer-containing eye products in individuals with cystic fibrosis, patients being cared for in critical care settings, the severely immunocompromised and patients awaiting lung transplantation has been stepped down.
Original Alert
The UKHSA is investigating a novel cluster of Burkholderia cenocepacia involving 20 cases across the UK. Preliminary epidemiological and microbiological investigations have identified a potential association with carbomer containing lubricating eye gel. Investigations into the link between the cluster and carbomer eye gels are ongoing, and these findings are not conclusive at this stage.
Based on the UKHSA’s findings the manufacturer has issued a product recall of specific brands of carbomer in the following notice, which we urge you to read DSI/2023/11.
The brands are AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel.
Ophthalmology departments should engage with pharmacy colleagues to ensure all products identified in the recall are quarantined and returned via the supplier’s approved process.
As a precautionary measure, and until further information is available, the RCOphth recommends members avoid prescribing carbomer containing eye gels where possible in the following groups:
- individuals with cystic fibrosis
- critical care inpatients
- severely immunocompromised patients
- patients awaiting lung transplantation.