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Safety Alert – Zeiss Lucia 611P intraocular lens

10 April 2019

The College has been made aware of two ophthalmic units with a run of a small number of cases of fibrin membrane deposition in association with the Zeiss Lucia 611P intraocular lens.

In these cases, the patients presented from a few days up to 6 weeks postoperatively, with a painless white eye, very mild or no uveitis, associated with a fibrin membrane at the level of the anterior capsule incorporating the capsulorrhexis edge in front of the lens. This was sometimes quite dense, mistaken in some cases initially as intralens opacification and in a number of cases required tPA (tissue plasminogen activator) or occasionally surgery to remove the membrane and restore vision.

A minority of those affected had some risk factors for postoperative inflammation, such as previous surgery or pathology, or small to medium pupils (not requiring iris hooks or expanders), but most of the patients had no specific risk factors.

The lens company has issued a statement1 and are investigating. The MHRA has been informed.

Members are asked to be vigilant for such cases associated with this IOL but also with any other IOL brands and follow local procedures to report these as incidents and to also inform the MHRA2.

Members are encouraged to make the College aware of such incidents as we can be proactive in raising concerns to MHRA when appropriate.  So please report definite cases associated with the specific brand of IOL or any other brands to [email protected], Head of Professional Support.

We will notify members of any further developments.

  1. Zeiss Statement
  2. https://www.gov.uk/report-problem-medicine-medical-device