Safety Alert: Raised IOP following cataract surgery using EyeCee One Lenses

  • 13 Feb 2023
  • RCOphth

Further to the release of the Device Safety Information issued on the 26 January, the MHRA released a national patient safety alert on the 1 February.

The College has been in discussion with clinical leads from some of the centers impacted by this alert and together we have devised the following consensus points:

  • Patients from January, and those who have missed their 4 week follow-up appointment, are the most likely to benefit from earlier intervention. Departments should prioritise these patients for contact and IOP screening either via primary care optometrists or hospital eye services.
  • Patients need to be contacted via a method the department has capacity to achieve within 2 weeks ie letter, telephone calls, emails etc. Prioritisation of capacity for telephone communication should be for patients who have not been to a 4-week follow-up appointment. Departments should consider the accessibility of communication formats for the patients affected.
  • Affected patients are commonly presenting with a high IOP of >40mmHg. Departments have found that intensive medical treatment, including topical steroid therapies with a more gradual taper, has been required to control IOP in these patients. Patients have had the best response to treatment when this has been achieved within 2 weeks of cataract surgery.
  • A cohort of patients suffering from elevated IOP are resistant to medical treatment and have required drainage surgery.
  • IOL exchange has been performed in a handful of patients however lenses that have been in situ for >2 weeks have been found to have a significant risk of a traumatic extraction

These incidents will place a significant burden upon the affected departments and the College will continue to work with the MHRA, NHS Patient Safety teams and our members to provide advice and guidance on managing the situation.

The College will facilitate the sharing of information between affected departments with regards to patient contact, screening strategies and the management of affected patients.

If you have any further queries regarding the MHRA National Patient Safety Alert or wish to be part of the peer-to-peer support network, please contact Jonathan Baker: [email protected]

Patients who are concerned are advised to contact the eye unit that carried out their recent cataract surgery.