Presentation
A 59-year-old man came to his ophthalmologist reporting ongoing visual problems. He had a complicated history that included uveitis, inflammation, and glaucoma with increased intraocular pressure, which required multiple procedures and steroid treatments.
Past procedures included right eye vitrectomy, right eye cataract surgery with lens placement, steroid implant device, trabeculectomy, and glaucoma valve placement. Vision in the right eye was limited from many years of inflammation and glaucoma, and the patient had decreased vision in the left eye.
The patient had myopia in both eyes, and was noted to have posterior subcapsular cataracts. Documented visual acuity with correction was 20/40 in the right eye and 20/40 in the left eye. Cataract extraction with lens implantation was planned for the left eye, to be followed by the right eye a week later. To improve the myopia that remained in the right eye after the prior cataract surgery, the ophthalmologist planned to take the patient back to surgery to implant a piggyback (additional intraocular) lens to achieve binocular visual improvement.
Physician action
The ophthalmologist performed cataract surgery in the left eye with implantation of a +10 diopter power intraocular lens. The procedure was uncomplicated, and the patient did well postoperatively.
A little over one week later, the ophthalmologist returned the patient to surgery for the same procedure on the right eye. Due to the patient’s past cataract surgery with residual myopia, the ophthalmologist felt he had the best opportunity for good visual outcome in the right eye by implantation of a piggyback lens with a negative polarity. The physician ordered a -10 diopter lens from the manufacturer. On the date of the procedure, the ophthalmologist examined the lens package in the operating room and noted that the box label identified the lens as a 10 diopter lens, but did not specify the polarity (+ or -).
The physician performed the procedure with the lens, and documented in his operative report that the lens box did not indicate the polarity and that he assumed that the lens was a – 10 diopter lens as ordered. At the conclusion of the procedure, the patient could not see with the right eye, and the ophthalmologist suspected that the wrong lens may have been used. The ophthalmologist called the manufacturer and discovered that they did not label their packages containing positive lenses with a positive polarity sign (+), and that he had indeed implanted a + 10 lens instead of a – 10 as intended.
The physician explained the situation to the patient and documented an addendum to his operative report indicating what he felt to be a “company mistake.” The ophthalmologist removed the + 10 lens 2 days later and replaced it with a -10 lens. The patient had a complicated course and developed corneal decompensation with corneal erosions, which may occur after multiple ocular surgical procedures.
Several months later, the ophthalmologist performed a revision to the glaucoma valve he had previously placed because he felt it could be causing corneal edema. Vision in the right eye improved temporarily to 20/100 but regressed to 20/200 and eventually to 20/400. The patient was referred to a corneal specialist and eventually had corneal transplantation in the right eye. The corneal graft ultimately failed, and the patient is considering another corneal transplant or partial enucleation.
Allegations
The patient filed a lawsuit against the lens manufacturer, the hospital, and the ophthalmologist. The patient claimed that the ophthalmologist was negligent in placing the incorrect lens during his right eye surgery. The patient claimed that the physician should have rescheduled the surgery due to the uncertainty about the polarity of the lens and that the multiple procedures caused over-filtration of the glaucoma valve. This led to decreased intraocular pressure, corneal edema, and the need for corneal transplant.
Legal implications
Consultants who reviewed the case felt that until the time of the implantation of the piggyback lens, the ophthalmologist’s treatment fell within the standard of care. Consultants did not criticize the ophthalmologist’s choice to perform the piggyback lens implantation. The unclear labeling of the lens was documented in the physician’s operative report, which clarified that the lens was not marked with a positive (+) or negative (-) polarity. The physician also documented that he assumed the lens was the correct one. While consultant reviewers acknowledged that the labeling on the lens packaging was confusing, they felt that the implantation of the wrong lens fell below the standard of care.
Disposition
The case was settled on behalf of the ophthalmologist. The lens manufacturer and the hospital also settled with the plaintiff.
Risk management considerations
The ophthalmologist examined the lens package in the operating room on the day of the procedure, and documented in the operative report that the package did not indicate whether the lens was positive or negative polarity. Although the physician ordered the correct polarity lens and hospital purchasing orders showed that the correct lens was ordered, the manufacturer delivered the wrong one to the hospital. This type of lens is not commonly used, and the physician was uncertain about how the package should have been labeled. Unfortunately, the confusing labeling was not investigated and the incorrect lens was used. When performing procedures, physicians should strive to remove any doubt regarding the materials used. At times, it may even be necessary to delay or suspend a procedure until it can be verified that the correct products are being used and questions can be resolved.
