15. We look at whether there are signs an organisation got something wrong. We do this by comparing what should have happened with what did happen. We have done this and we have not seen any signs that something went wrong.
16. All medical procedures carry risks and complications can happen that are not preventable. Mrs A experienced a posterior capsular rupture (PCR). Our ophthalmology adviser said this is a well-known complication of cataract surgery that cannot be prevented.
17. Mrs A consented to having a cataract procedure, with a risk of complications that may need further corrective surgery. The RCO guidance on communicating and obtaining consent says ophthalmologists should: ‘obtain valid consent from the patient according to GMC, national and Trust guidelines, or from the parent in the case of a minor.’
18. The guidance does not say the risks that need to be listed in a consent form but it suggests the form needs to comply with GMC and other national guidance.
19. The RCO’s cataract consent form template is guidance for Trusts if they want a written consent form, but it does not need to be completed in exactly the same way as the template.
20. GMC’s guidance on decision making and consent says:
‘it would not be reasonable to share every possible risk of harm, potential complication or side effect. Instead, you should tailor the discussion to each individual patient, guided by what matters to them, and share information in a way they can understand.
‘You should usually include the following information when discussing benefits and harms:
a. Recognised risks of harm that you believe anyone in the patient’s position would want to know. You’ll know these already from your professional knowledge and experience.
b. The effect of the patient’s individual clinical circumstances on the probability of a benefit or harm occurring. If you know the patient’s medical history, you’ll know some of what you need to share already, but the dialogue could reveal more.
c. Risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the patient about what matters to them.
d. Any risk of serious harm, however unlikely it is to occur’.
21. The Trust’s consent form shows good practice in line with guidance from the RCO and GMC. It outlines the risks associated with the surgery Mrs A had and the significance of them.
22. The Trust’s consent form for the operation lists a 1 in 100 risk of further surgery. This includes the complication Mrs A experienced. Mrs A signed the consent form which listed this risk, before she had cataract surgery on her left eye.
23. Our ophthalmology adviser confirmed Mrs A’s operation was done by a doctor with an appropriate level of experience. This registrar was supervised by a consultant. The complication was recognised immediately, and the supervising consultant took over quickly.
24. Our ophthalmology adviser told us the Trust made Mrs A’s eye safe at the end of the cataract procedure and gave the correct post-operative drops and treatment. It made a timely referral to, and there was more treatment by, the vitreoretinal service.
25. We have seen no signs Mrs A did not get the correct care during cataract surgery and post-operatively. Unfortunately, she experienced a recognised complication which was dealt with quickly. We will take no further action on her complaint.
26. We recognise the distress Mrs A felt at the time of the events and the frustration and inconvenience she experienced with her medication regime, as well as travelling to and from London for further treatment.
27. We are grateful to Mrs A for bringing her concerns to us. We know this has been an incredibly distressing time for her.