Risk Management

Risk Management Lessons from a Review of 168 Cataract Surgery Claims

By Dean C. Brick, MD

Digest, Summer 1997

One of the advantages of being a single-specialty insurer is the ability to collect and analyze data on a large number of professional liability claims related to one specialty, one subspecialty, or even one procedure and to use this data to develop risk management programs specific to certain subspecialties or procedures.

In an attempt to develop risk reduction strategies for cataract surgery, I reviewed 168 closed claims involving cataract procedures reported to OMIC from its inception to March 31, 1997. Cataract procedures represented 33% of the 515 OMIC claims closed during this 10-year period (Fig.1). Of these 168 claims, 37 (22%) were closed with an indemnity payment made on the behalf of the insured. Although these 37 cases made up only 7% of all OMIC claims, indemnity payments on their behalf totaled more than $3 million, representing 24% of the total indemnity paid by OMIC during this period.

These numbers indicate that cataract surgery is a very risky procedure for the general ophthalmologist and risk reduction strategies are needed. By tabulating the most common clinical events leading to claims, strategies can be developed to help decrease the frequency and severity of claims in connection with cataract surgery.

Surgical Complications

One way to reduce risk is to identify or anticipate incidents and complications that increase the risk of a suit and employ activities designed to prevent or decrease that risk. To determine if a surgical complication is a good indicator of increased risk, I measured the incidence of surgical complications for all closed cataract claims, tabulating only those claims with sufficient clinical data to determine if a surgical complication had occurred. The most common surgical complications found were ruptured posterior capsule, vitreous loss, retained lens material, iris damage, and choroidal hemorrhage. Surprisingly, the data showed that a surgical complication was recognized at the time of surgery in less than 50% of cases. This emphasizes the importance of performing timely and accurate dictation of the operative report. Surgeons are usually careful to dictate complete reports following surgeries in which a complication has occurred; however, in cases in which there is no surgical complication, the surgeon may relax and make the operative report less complete and thus more prone to attack by a plaintiff’s lawyer. Worse still, the operative report may not be dictated until some time later after a complication has been recognized. Such reports usually sound defensive and self-justifying and are difficult to defend. Therefore, the absence of a complication during surgery should be of little reassurance to the wary surgeon, who must always use good risk management techniques to decrease the likelihood of a claim.

Poor Visual Outcome

Poor visual outcome is another clinical area that might be indicative of increased risk. Again, only those cases in which the final best corrected visual acuity was available were reviewed. Not surprisingly, I found that the largest group of claims resulting in indemnity payments had poor visual outcomes, but the second largest group had good or excellent visual results (Fig. 2). Thus, a good visual result does not negate the risk of a liability suit, and the wary surgeon must continue to use risk-reducing activities even in uncomplicated cases with good visual results. Figure 3 demonstrates visual outcomes in claims where no indemnity payment was made on behalf of the insured.

As expected, the largest group consisted of claims with a good visual result. The beleaguered surgeon may find some relief in the fact that the second largest group consisted of claims with very poor visual results, demonstrating that even with a poor visual result, a claim may be defended if the surgeon has followed some risk reducing strategies. These strategies can be found by examining certain groups of claims.

Claims were grouped by the complication that resulted in the decreased vision or subjective complaints of the patient and that most often prompted the patient to file a liability claim (Fig. 4). Often, there was a series of complications that in the end resulted in the claim; for example, the patient suffered a ruptured posterior capsule with vitreous loss, had an anterior vitrectomy, and developed endophthalmitis followed by a retinal detachment and phthisis. In this instance, the case would be classified under endophthalmitis as it was the infection that ultimately led to the loss of vision and the claim.

IOLs Account for Largest Number of Claims

The largest group of identifiable claims involved intraocular lenses (Fig. 5). This group included cases in which it was alleged that the wrong power, wrong size, or wrong type of IOL was used, that a defective IOL was used, or that the IOL became decentered or dislocated postoperatively. Since the FDA has approved all lenses commonly in use, it is generally easy to defend the use of an alleged defective IOL. In both instances where this was alleged, a closed loop A/C IOL had been used and both cases closed without an indemnity payment. Decentration of an IOL is also a well documented occurrence and is listed in most consent forms. It is very defensible, and all cases of this type closed without payment. Allegations of the wrong size or type of IOL also were defensible provided there was documentation explaining why the surgeon chose that IOL and a record that the eye had been measured to determine the correct size. This was obviously most important with A/C IOLs but also significant if a P/C IOL was placed in the sulcus instead of the bag.

This leaves two major problem areas with respect to intraocular lenses: insertion of the wrong power IOL and subluxation of the IOL. The single largest group of claims related to the IOL involved insertion of the wrong power IOL. Events leading up to the use of the wrong power IOL varied and included use of the SRK I formula for ametropia; the circulating nurse handing the surgeon the wrong IOL; incorrectly labeled IOLs and/or confusion over the manufacturer’s number for the IOL; and incorrect biometry or keratometry. These mistakes can be prevented by following modern IOL formulas, employing a few experienced technicians, and using a preoperative checklist. One ophthalmologist suggests having a checklist of the IOL choices for each patient taped to the side of the phaco machine for a final check before insertion. It is likely that most juries will find that the surgeon is ultimately responsible for the correct IOL being inserted, and the surgeon should be prepared to recognize and correct any mistake made by nurses or technicians. Despite the fact that most of these patients had excellent visual results, it is this group for whom the bulk of indemnity was paid. These payments tended to be smaller than payments to other patients with IOL-related problems, however, averaging $28,000 for wrong power IOL cases compared with $87,500 for cases of subluxed IOLs.

Cases in the latter group all involved a secondary surgery and frequently additional complications such as retinal detachment. These claims can be particularly hard to defend if the dislocation occurs soon after surgery. It usually comes down to careful scrutiny of the operative report: if it is well documented that complications during surgery were recognized and treated appropriately and that the correct type of IOL was used and checked after insertion to see if it was secure, the case may be defensible. Thus, if the surgeon elects to use a P/C IOL in the face of a ruptured capsule (which may well be the best choice for the patient), the surgeon should make sure that the procedure, recognition of complications, and their treatment is documented in the operative report. With this type of documentation an expert usually can be found to defend the surgeon’s choice of IOL.

Endophthalmitis Claims are the Most Costly

While complications related to the IOL were the most common cause of claims, they ranked third in terms of total indemnity paid. Claims related to endophthalmitis composed the group with the largest amount of indemnity paid by OMIC and also the largest percentage of claims in any group resulting in an indemnity payment. These findings are interesting because endophthalmitis, a known complication of cataract surgery, is almost uniformly mentioned in consent forms for cataract surgery and should be defensible. The key to any defense is the ability to obtain expert defense testimony, and that is where most claims of endophthalmitis fall short. The most common problem areas involve delayed diagnosis or failure to use consultants soon enough. Although the use of prophylactic antibiotics preoperatively, intraoperatively, and postoperatively is frequently debated, this issue seldom arose during the claims reviewed here. Far more common was the fact that while unusual inflammation was documented postoperatively in the chart, it was not aggressively treated or evaluated. Such cases would have been more defensible if the surgeon had seen the patient more often once the increased inflammation was noted and used consultants to confirm the diagnosis and management plan.

While there is no standard of care for the use of prophylactic antibiotics in cataract surgery, the surgeon’s method of patient preparation should include documentation of whatever means he or she employs to help prevent endophthalmitis; for example, use of povidone iodine, draping of the lid margins, pre- or post-operative antibiotics, etc. After surgery, if unusual or severe inflammation is observed and documented, the patient should be examined at frequent intervals even if that means seeing the patient off-hours or on weekends. Clinical findings should be documented at each visit to justify the physician’s plan of treatment. Finally, if there is any doubt about the possibility of infection, a second opinion should be obtained to help reassure the patient. A second opinion also makes it easier to later defend a claim and obtain expert witness support should the need arise.

Retinal Complications of Cataract Surgery

Claims related to retinal complications of cataract surgery were the second most common type of claim (Fig. 4), ranking second in both total indemnity payments and average indemnity payment ($72,000 for retinal versus $177,000 for endophthalmitis). Seventeen of these claims were related to retinal detachment subsequent to cataract surgery; however, claims settled with an indemnity payment usually followed a surgery complicated by rupture of the posterior capsule, subluxation of the nucleus, and retinal detachment. These cases also were associated with high average indemnity payments. Cases associated with cystoid macular edema (CME) and age-related macular degeneration (ARMD) uniformly closed without any indemnity payments.

During my analysis, it was evident that the outcome of retinal claims frequently hinged on how the complication was managed during surgery and how soon the patient was referred to a specialist. In instances where there were allegations of delayed diagnosis of retinal detachment following surgery, earlier evaluation and referral to a specialist might have prevented the claim or made it more defensible. Surgeons who are not experienced and trained to perform deep vitrectomy or retrieve nuclear fragments deep in the vitreous are better off completing the anterior part of the procedure and referring the patient quickly to a specialist. Although the optimal timing for referral may not be established, it is prudent to refer the patient sooner rather than later.

Corneal Complications Occur Infrequently

Claims related to corneal complications of cataract surgery are relatively infrequent among OMIC insureds (Fig. 4), which is surprising considering that the population undergoing cataract extraction frequently has underlying corneal disease (guttata). This dichotomy probably reflects the fact that preexistent corneal disease is easily visible preoperatively and the potential for corneal edema is discussed with the patient preoperatively. It also supports the fact that claims usually result from unexpected adverse outcomes and that patients who are well educated and informed about the possibility of an adverse outcome prior to surgery are less likely to sue. Other claims related to the cornea followed corneal burns from phacoemulsification (2), descemet’s detachment (1), and corneal erosions after cataract extraction (1). The two cases associated with indemnity payments involved other complications, a dislocated IOL in one case and a wrong power IOL in the other. Risks associated with corneal complications may be reduced through the use of proper informed consent and documentation of preoperative findings and special precautions taken during surgery to protect the cornea. It is also important to maintain adequate flow during phacoemulsification to cool the tip and prevent corneal burns.

Claims related to the iris were notable only because of the relative frequency with which they occurred (Fig. 4). Most cataract surgeons view the iris merely as an obstruction to surgery; however, most of these claims resulted from distortion of the iris and demonstrate the cosmetic and functional importance of the iris even among older patients. Although these claims are usually settled without payment, good surgical technique and thorough patient preparation in cases where it is likely the iris will be distorted might prevent them in the first place.

Finally, there was a large group of miscellaneous claims (Fig. 6). Most of these claims occurred only once or twice; however, a few occurred more frequently. Needle perforations of the globe during anesthesia or postoperative injections occurred four times, emphasizing the need for care when using small bore sharp needles to give injections around the eye. Glaucoma-induced visual field loss occurred in five cases, three of which resulted in indemnity payments. These claims involved postoperative complications that could have been prevented by more aggressive management of the associated glaucoma and the appropriate use of consultants earlier in the case. Claims involving expulsive hemorrhages during surgery occurred six times and also were usually defensible. Recognition of the complication and its treatment need to be documented along with prompt referral to a specialist. Suture irritation was a surprisingly common claim that has disappeared in recent years with single or sutureless technique.

General Risk Reduction Strategies

While every case reviewed was unique and its outcome depended on a number of individual variables, there were some recurring problems that could have been prevented or mitigated by employing the following risk reduction strategies.

1. Document complete preoperative exam, including indications for surgery. (Obviates claims of unnecessary surgery.)
2. Use informed consent specific to cataract surgery. Additional documentation of any findings increasing the risk of surgery is also very useful (e.g., diabetes).
3. Dictate a complete operative report immediately following surgery, including:
   • Steps taken to prevent infection.
   • Recognition of any complications intraoperatively.
   • Surgeon’s response to any recognized complications.
   • If a different IOL is implanted than anticipated, the reason for choosing that IOL and how the size was determined.
4. Follow-up exams should have adequate clinical data and be scheduled as frequently as needed.
   • Frequency should be increased if complications occurred during surgery or are documented postoperatively.
   • Patient complaints of flashes, floaters, pain, etc., should be investigated thoroughly during the postoperative period.
5. Never make any changes or additions to the past record after a complication is recognized. This type of alteration can make a defensible claim indefensible.
6. Use consultants early if there are significant complications that may result in a claim.

Specific Risk Reduction Strategies

These should be used in addition to general strategies.

1. Related to IOL usage:
   • Employ one or two technicians who are well trained to perform keratometry and biometry.
   • Review the scans and keratometry data when choosing the IOL.
   • Use one or two styles of IOLs regularly to prevent confusion about IOL constants or model numbers.
   • Use a third generation formula for IOL selection.
   • Keep a list of IOL choices for that day’s patients on the side of the phaco machine and check it just prior to insertion.
   • Use a checklist preoperatively to document data, informed consent, and any pre-op and post-op instructions that were given to the patient. (Contact OMIC’s Risk Management Department for a sample checklist, which also serves as a cataract surgery face sheet.)
2. Related to endophthalmitis:
   • Document any specific preventative measures taken.
   • If infection is possible, increase the frequency of observation.
   • Document findings carefully in chart with the plan.
   • Use consultants early if inflammation is excessive.
3. Related to retinal complications:
   • Do not operate beyond your experience or training in removing subluxed nuclear remnants.
   • Use consultants early.
4. Related to miscellaneous complications:
   • Be careful if using sharp small bore needles for periocular injections. Pre-dulled needles are preferable.
   • Monitor postoperative pressures closely and treat aggressively if indicated.

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