Originally published September 2012
Cataract surgery is a common and safe surgical operation in Canada. This article reviews the medico-legal issues related to the procedure as experienced by CMPA member ophthalmologists. It focuses on issues identified in the pre-operative, intra-operative, and post-operative periods of cataract surgery.
The CMPA conducted a review of medico-legal cases involving ophthalmologists between 2006 and 2011. A total of 381 cases specific to non-cosmetic ophthalmology were reviewed, of which 281 cases were closed. In 65% of cases, the care provided was supported by peer experts and the outcome for the physician was favourable. The main reasons patients initiated a legal action or complaint were allegations of inadequate assessment and lack of informed consent. Of these 381 cases, cataract surgery was the most frequent reason patients sought treatment (37%). The extracapsular phacoemulsification technique was used in 89% of these cases.
The main pre-operative medico-legal issues were patient assessment and informed consent.
Peer experts retained to review the care in this series of cases were of the opinion that pre-operative care should have included the following:
- a comprehensive medical and ophthalmic history including:
- medications and allergies
- pre-existing medical conditions (e.g. diabetes, hypertension)
- ophthalmic conditions (e.g. history of a blocked tear duct)
- an adequate patient assessment including:
- visual acuity assessment
- a careful and complete ocular examination (e.g. to identify other ocular conditions including retinal problems)
- appropriate examinations such as intraocular pressures (IOP)
- determination of the correct intraocular lens (IOL)
- evaluation of patient and surgeon factors that might influence the decision to use a particular anaesthetic technique
- detailed, clear, and legible documentation of:
- the medical and ophthalmic history
- the patient's assessment
- consultations or referrals in the medical record
Based on Canadian legal judgments, the following suggestions may assist ophthalmologists.
The physician should disclose to the patient the nature of the proposed cataract surgery, any material risks, and any special risks.1 Even if a risk is a mere possibility that ordinarily might not be disclosed, if it carries serious consequences, for example blindness, it must be regarded as a material risk and requires disclosure.
Physicians should be alert to a patient's specific risks related to the proposed treatment and should discuss these with the patient. A patient's special circumstances might require disclosure of potential, although uncommon, hazards of the treatment when ordinarily these might not be seen as material (e.g. the risk associated with operating on a functionally monocular patient).
Although consent discussions tailored to the patient's particular circumstances are most important and should not be replaced, these can be supplemented by print materials. The patient should have the opportunity to further discuss the therapeutic choices and risks.
Where a part or all of the treatment is to be delegated (e.g. to a resident or anaesthesiologist), patients have a right to know who will be involved in their care.
Peer experts were of the opinion that informed consent should have included:
- information about the different anaesthetic techniques available and associated risks
- the opportunity for the patient to have questions answered by the ophthalmologist, rather than routinely answered by staff
Patients may have unrealistic expectations related to their visual acuity following cataract surgery. For example, to minimize misunderstandings it is helpful prior to surgery to discuss the possibility of requiring corrective lenses after surgery.
The experts also noted that the consent discussion should have been appropriately documented.
The most frequent intra-operative issues were related to capsular tear, selection of the wrong IOL power, and injury from retrobulbar injection. Although peer experts in the analyzed cases considered intra-operative capsular tear and retrobulbar injection injury inherent risks of cataract surgery, they were critical of the items described below.
Intra-operative capsular tear with or without lens fragment retention and vitreous loss
- not considering the patient's capacity to cooperate during surgery
- failure to detect the presence of vitreous body in the operative wound or to recognize the retained lens fragments during surgery
- failure to perform an anterior vitrectomy
- scant operative notes not reflective of the surgical events (e.g. no mention of a capsular tear or retention of lens fragments)
- illegible or altered operative notes
Selection of the wrong intraocular lens power
- choosing the wrong lens power because of an altered OR list that resulted from inadequate annotations
- failure to verify that the correct IOL lens was selected for the correct patient and the correct eye prior to the start of surgery
Injury from retrobulbar or peribulbar injection
There is a range of anaesthesia options for cataract surgery (e.g. topical, general, retrobulbar, and peribulbar), with topical anaesthesia currently being the most popular technique. However, the choice of anaesthesia depends on both patient and surgeon factors. Although injury from retrobulbar anaesthesia may occur, experts commented that this choice of anaesthesia is still appropriate in specific circumstances.
In addition to retained fragments following a capsular tear, other post-operative complications included retinal detachment, infection (e.g. endophthalmitis, Toxic Anterior Segment Syndrome [TASS]), and corneal edema. Physicians have an obligation to properly inform patients of complications in the post-operative or post-discharge period, most specifically about clinical signs and symptoms that may indicate the need to seek immediate assessment.
Ophthalmologists also have a duty to provide or arrange adequate follow-up care for patients after cataract surgery. Care may be transferred to another healthcare professional such as an optometrist. It is the ophthalmologist's duty to be satisfied that the follow-up care can be adequately provided by an optometrist or if an ophthalmologist should provide the care. In some regions, ophthalmologists are more likely to work with family physicians or other healthcare professionals, and the same principles apply. Effective communication is essential. The individual providing the follow-up care should be made to feel welcome to call the operating surgeon if concerns arise.
Peer experts in the cases analyzed identified the following themes related to post-operative care:
- unclear advice to patients of any changes to their treatment plan (e.g. presence of bandage contact lens)
- the lack of reasonable post-operative discharge instructions
- the failure to promptly assess a patient who develops sudden or progressing visual symptoms (e.g. post-surgical loss of vision)
The peer experts were also of the opinion that the documentation in the medical record should have been more consistent and detailed (e.g. relevant findings at follow-up visits).
They further commented that an office policy for staff to follow when communicating with a patient or physician about a patient's concerns would be helpful. The policy should include the requirement to document the communication.
Peer experts in the cases analyzed identified the following themes:
- inadequate follow-up care of the patient by not performing thorough eye examinations
- less than timely referral to a retinal specialist when fragments were found post-operatively or if a retinal detachment occurred
- inadequate communication when transferring care to optometrists or other health professionals
This case illustrates the importance of documenting the consent discussion and providing adequate follow-up care after cataract surgery.
A 73-year-old diabetic patient with glaucoma and bilateral cataracts underwent cataract extraction of the left eye. During phacoemulsification, the ophthalmologist realized the posterior capsule had ruptured and an anterior vitrectomy was performed. An IOL implant was attempted but abandoned. Peripheral iridectomy was performed and the wound was sutured.
The next day, the patient's left eye intraocular pressure (IOP) was 16 mmHg and he could count fingers when his vision was tested.
The ophthalmologist noted inflammation and prescribed topical anti-inflammatory, antibiotic, and dilator drops.
The patient was seen 1 week later and a nuclear fragment was identified in the anterior chamber. The patient's IOP, vision, and inflammation remained unchanged, and the treatment for the inflammation was continued. Two weeks later, the patient underwent phacoemulsification of the retained lens fragment in the anterior chamber. One week later, the patient complained of absence of light perception in the left eye. The patient was referred to a retinal specialist 7 days later who confirmed a total retinal detachment. The patient subsequently developed phthisis bulbi (atrophy) and never recovered vision in his left eye.
Peer experts in this case agreed with the ophthalmologist's decision to operate on a well documented, progressive cataract. However, they were critical of the following aspects of the ophthalmologist's work:
- inadequate documentation, including the consent discussion, in the medical record
- failure to perform a thorough examination of the vitreous following intra-operative posterior capsule rupture
- inadequate post-operative follow-up care. The ophthalmologist did not perform an examination of the retina or ocular ultrasound and did not look beyond the absence of a lens to determine the reasons for the patient's visual loss. He also failed to inspect the vitreous during the second surgery.
Experts agreed that a timely referral to a retinal specialist before the second operation would have been prudent. Without expert support, a settlement was paid to the patient by the CMPA on behalf of the ophthalmologist.
Based on the experts' opinions for the cases analyzed, the following risk management considerations are suggested.
- A comprehensive pre-operative assessment should include a complete medical and ophthalmic history as well as a comprehensive eye examination.
- Care should be exercised to determine the correct IOL.
- Significant risks, complications, and anticipated outcomes associated with the proposed surgery and available alternatives should be part of the consent discussion. The patient should also be given the opportunity to further discuss the therapeutic choices and risks.
- Complete, timely, and legible documentation, which should include the patient's medical and ocular history, assessment, and consent discussion, may be a physician's best defence if the care is called into question.
- Considering the patient's capacity to cooperate during cataract surgery may help in determining the optimal anaesthesia technique.
- Recognizing and managing intra-operative capsular tears promptly may reduce associated complications and prevent the need for subsequent procedures.
- Operative notes should be detailed, legible, and reflect any surgical events.
- Modifications to the operative notes, or any medical records, must be made carefully and accurately according to applicable regulations and guidelines, such as policies published by medical regulatory authorities (Colleges).
- The patient should be made aware of any need for follow-up, who will be providing the follow-up, and how the arrangements will be made.
- The patient and family should be informed about how to recognize the symptoms and signs that would alert them to seek immediate treatment. The advice should be tailored to the patient's specific clinical situation.
- The discussion and advice should be documented in the medical record.
- A patient who develops sudden or progressing visual symptoms should be promptly assessed.
- Canadian courts generally consider material risks as being those a reasonable person, in the same circumstances, would want to know before consenting to an investigation or treatment. This would include complications that occur commonly, and also those that occur rarely but have significant consequences. A court may consider the patient's physical or psychological makeup will make even an uncommon risk special or more important for that patient.