Patient safety in intra-ocular lens implantation called into question

Posted: 05/12/2017

Advances in technology and clinical techniques in recent years have led to vast improvements in the management of patients with visual problems. Those suffering cataracts and lens-related problems are now able to undergo artificial lens implants, with the natural lens either retained or removed. Such implants are increasingly sophisticated, with multi-focal implants widely available. The potential advantages to patients are great, restoring vision and vastly enhancing quality of life. There are, however, risks associated with these procedures.

The Healthcare Safety Investigation Branch (HSIB) was established in England earlier this year. It comprises a team of investigators who review incidents in which patient safety is compromised with the aim of identifying and promoting recommendations to avoid future recurrences. The team is funded by the Department of Health, but acts independently and has the right to wide access to review and evaluate information relevant to the issues it investigates.

HSIB has announced that it is currently investigating the implantation in a cataract patient of an incorrect replacement lens. The circumstances in which this occurred are yet to be published, but the event is of concern. Removing an artificial implant that has been incorrectly inserted is complex and highly technical, with different risks to removing the original natural lens. The scope of the investigation will include how the incorrect lens came to be inserted in the first place. A key part of the pre-operative investigation and advice from any ophthalmic surgeon specialising in this field is to determine the correct strength of implant to be used.

Andrew Clayton of Penningtons Manches’ clinical negligence team, who has a specialist interest in ophthalmic issues, comments: “We act in a number of cases in which patients experience poor outcomes following intra-ocular lens implants. This surgery is becoming increasingly common and commoditised. While the vast majority of people experience good results, the risks can leave some patients with devastating loss of vision.

“We are currently advising on a claim where multi-focal lenses were implanted in a patient without any prior aberrometry tests. These tests determine refractive aberrations in the eye and are part of the process to establish whether a particular patient is suitable for lens replacement. In this case, it is admitted that had these tests been properly performed, our client would have been told he was not a suitable candidate. Instead, multi-focal lenses were implanted. He has been advised against having these lenses removed because the procedure would carry high risks of further damage. He has no functional vision except when wearing contact lenses but his eye disease means he can tolerate them only for a few hours each day. The rest of the time he has no meaningful sight.

“In a separate case we settled earlier this year, a patient was wrongly fitted with an artificial lens despite expressly refusing permission for the procedure and suffered considerable anxiety over the strength of the implant the surgeon had inserted. These cases highlight the potentially devastating risks associated with ocular implants and any investigation that strengthens safeguards for patients is welcome.”

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