ROBERT J. ARLEO, MD, FACS
This situation, unfortunately, happens with frequency. The saving grace in this case is that the nurse recognized the problem while the patient was in the OR. The obvious choice in this patient is to explant the IOL and replace it with an appropriately powered lens. Another situation in which to explant and replace a lens intraoperatively would be for a damaged optic or haptic.
The technique for explantation is straightforward and can be performed even weeks after the IOL was inserted. After creating a paracentesis 180º away from the original incision, I would reenter the original incision. I would inject Viscoat (Alcon Laboratories, Inc.) to coat the back of the cornea and then underneath the anterior capsulorhexis and behind the IOL’s optic. If the IOL had been in the bag for some time, I would carefully separate the IOL from the anterior capsulorhexis with a 30-gauge needle.
Next, I would use Viscoat to prolapse the IOL’s optic anterior to the capsulorhexis and rotate the lens to bring its haptics out of the bag and anterior to the iris. I would then position the lens so that its haptics were oriented 90º perpendicular to the incision.
My next step would be to place a cyclodialysis spatula beneath the optic of the IOL while carefully keeping the tip of the instrument just at the edge of the optic. I would place a folding forceps (DK 7741; Duckworth & Kent Ltd., Hertfordshire, England) on top of the cyclodialysis spatula and fold the IOL downward. Before fully closing the blades of the forceps, I would withdraw the cyclodialysis spatula. Then, I would rotate the forceps to position the haptics horizontally and remove the IOL from the patient’s eye.
Preventing this type of complication is essential. My group has a multiple-stepped process. The IOL powers with the patient’s name are faxed to the OR in advance of the surgery, and the OR nurse pulls the IOL with the patient’s name attached to it. I keep my IOL calculation sheet for each patient posted on the wall. After entering the room but before loading the IOL, I check the power and confirm that the IOL is correct. The case for the IOL is left on the table. Prior to its insertion, the nurses reconfirm that it has the correct power and patient’s name, as written on my calculation sheet.
FRANCESCO CARONES, MD
I would remove the wrong IOL and implant the correct one immediately. My standard implantation technique for this type of IOL involves a 2.6-mm temporal incision and injection of the IOL with a Monarch C cartridge (Alcon Laboratories, Inc.) in a Royale injector (ASICO, Westmont, IL). Discovisc (Alcon Laboratories, Inc.) has become my routine viscoelastic for this surgery.
In order not to enlarge the original incision, I would proceed as follows. First, using a standard IOL manipulator hook, I would rotate the IOL to move it from the capsular bag into the anterior chamber. This step is quite easy, thanks to the very soft and manageable loops this IOL has. Any kind of viscoelastic would therefore be suitable for protecting the endothelium.
With a modified Vannas scissors, I would then cut the IOL to be explanted into three pieces. During this phase, I would use a standard Buratto PMMA IOL holding forceps (Janach, Como, Italy) to firmly grasp the IOL, which tends to slip. After cutting the IOL, I would slide the pieces through the tunnel using the same forceps. I would then implant the correct IOL using my standard technique, as described earlier.
Regarding prevention, I do not store my IOLs in the OR but in an adjacent room, outside the sterile area. Usually, I select the IOL to be implanted before each patient enters the OR, where only one lens is available per case. This practice has thus far prevented the mismatching of IOLs to patients. If the IOL breaks, falls on the floor, or needs to be changed, I double-check the new one.
LISA BROTHERS ARBISSER, MD
I would handle this unfortunate mistake by explanting the lens and replacing it with the correctly powered implant. After filling the bag with a cohesive ophthalmic viscosurgical device (OVD), I would use a Lester lens manipulator to compress one haptic and easily lift the lens into the anterior chamber with a bimanual technique. I prefer to sandwich the lens with a dispersive OVD and cut it with an intraocular scissors, either completely in half while I support the distal end of the optic with a Sinskey hook through the sideport or two-thirds of the way while allowing it to rotate out of the unenlarged incision. I rarely refold the lens for fear of entrapping the iris, although the one-piece acrylic IOL is easy to fold intracamerally over a spatula inserted 180º away from the main temporal incision.
After the explantation of the original lens, the appropriately powered lens may be placed in the bag easily in the surgeon’s usual manner. One must carefully remove all of the OVD from the posterior as well as the anterior chamber with I/A.
If the original lens in this case remained in the eye without an exchange, the refractive result would likely be approximately -1.75D, which is a little more myopia than I would choose for blended vision. When I choose to make one eye slightly nearsighted, I aim for -1.25 to
-1.50D so that the patient’s depth perception is minimally disturbed. I only target slight uniocular myopia after preoperative counseling and according to the patient’s choice. I would not like to surprise a patient with such a result.
The maneuvers described earlier carry minimal risk and demand little time, but I believe it is ethically mandatory that the patient and family be informed of the error. An incident report should be logged at the surgery center or hospital, and the details should be dictated in the operative report.
I attempt to prevent this problem from happening by means of numerous checks and balances. I choose the IOL’s power and transcribe it onto a worksheet, which two nurses double-check. A nurse pulls the lens from inventory, and only the lens for the patient having surgery is allowed in the OR for that case. Subsequent patients’ IOLs remain in the hall outside the OR’s door. A form with the patient’s particulars is hung from the microscope, and the nurse verbalizes the IOL’s style and power as she hands it to me while checking the worksheet. No system is infallible, but we surgeons can strive for perfection.
D. MATTHEW BUSHLEY, MD, AND
TERRY KIM, MD
Exchanging the IOL and inserting the 18.00D SN60WF single-piece acrylic IOL prior to completing the case would be the most sensible action in today’s medicolegal environment. The decision is more difficult in this case, because the patient might be pleased with the refractive effect produced by the +20.50D IOL. The myopic result and monovision would likely reduce her dependence on corrective lenses for near tasks. On the other hand, the induced anisometropia could reduce this patient’s depth perception and increase her risk of falling.
The patient, however, elected and expects near emmetropia in her second eye, a result that was delivered almost perfectly in her first eye. Any refractive outcome that deviates significantly from her expectations based on preoperative discussions with the surgeon and the informed consent should be avoided if at all possible. Fortunately, the exchange of a one-piece acrylic lens is fairly straightforward and should pose little additional risk to this patient, who, to this point, has had an uncomplicated surgery.
We would fill the capsular bag and anterior chamber with viscoelastic material and, using a Sinskey hook, elevate and rotate the lens out of the capsular bag into the anterior chamber. The optic can then be grasped with a toothed forceps and partially bisected with a lens cutter or scissors. An alternative would be to refold the lens within the anterior chamber. With either approach, we would subsequently remove the IOL through the original corneal incision, insert the appropriate +18.00D IOL in our typical fashion, and remove the viscoelastic.
Every surgeon should develop a systematic approach for ensuring the implantation of the appropriate IOL. In a recently published joint statement with the American Society of Ophthalmic Registered Nurses and the American Association of Eye and Ear Hospitals, the AAO presented an IOL verification procedure for minimizing the chance of placing a wrong IOL and for improving patient safety.1
Additionally, most institutions have adopted a “time-out” procedure in the OR to be followed by the nurse, anesthesia provider, and surgeon in which they (1) correctly identify the patient, (2) confirm the procedure’s laterality with the surgeon and consent form, and (3) verify the IOL implant’s power and model with the patient’s chart, IOL order sheet, and surgeon. Moreover, nurses may tape informational sheets containing important demographics and the selected IOL powers to the wall or IV pole in the surgeon’s view for a cross-check prior to the IOL’s implantation.
ROGER F. STEINERT, MD
The power error in this case would theoretically result in a residual spectacle error of -1.66D, which would be a nice choice for monovision. That discussion and decision would have to have occurred preoperatively, however. A sedated patient on the OR table cannot give legally binding consent. Because the patient is still draped, the surgeon should immediately perform an IOL exchange with a technique of refolding the incorrect lens inside the eye (or cutting, if preferred) and replacing it with the correct IOL.
As the saying goes, nothing can be made foolproof, because fools are too clever. My colleagues and I try to minimize the problem described in this case with two rules: (1) the only IOLs in the OR are for the patient on the table, and (2) the circulator calls a time-out and verifies that the IOL is correct by holding its box next to the IOL order sheet in the chart for the surgeon to verify. The remaining danger is the possibility of two patients scheduled on the same day who have the same last name. The standard good hospital practice is to write in large, bold letters a warning on labels, charts, etc, when two patients with similar or identical last names are in the facility at the same time.
Section Editors Robert J. Cionni, MD; Michael E. Snyder, MD; and Robert H. Osher, MD, are cataract specialists at the Cincinnati Eye Institute in Ohio. They may be reached at (513) 984-5133; rcionni@cincinnatieye.com.
Lisa Brothers Arbisser, MD, is in private practice in Davenport, Iowa, and she is Clinical Adjunct Associate Professor at the John A. Moran Eye Center, University of Utah, Salt Lake City. Dr. Arbisser has performed clinical research for and has received travel support and honoraria from Alcon Laboratories, Inc., and Advanced Medical Optics, Inc. Dr. Arbisser may be reached at (563) 323-8888; drlisa@arbisser.com.
Robert J. Arleo, MD, FACS, is Medical Director of the Arleo Eye Institute in Ithaca, New York. He has received travel and stipend reimbursement for speaking as well as support for FDA clinical trials from Alcon Laboratories, Inc. Dr. Arleo may be reached at (607) 257-5599; rarleo@aol.com.
D. Matthew Bushley, MD, is Assistant Chief, Cornea and Refractive Surgery, Madigan Army Medical Center in Tacoma, Washington. He acknowledged no financial interest in any product or company mentioned herein. Dr. Bushley may be reached at (253) 968-1438; mbushley@aol.com.
Francesco Carones, MD, is Cofounder and Medical Director of the Carones Ophthalmology Center in Milan, Italy. He has performed clinical research for and has received travel support and honoraria from Alcon Laboratories, Inc.
Dr. Carones may be reached at +39 2 76318174; fcarones@carones.com.
Terry Kim, MD, is Associate Professor of Ophthalmology, Cornea and Refractive Surgery Services, Duke University Eye Center in Durham, North Carolina. He acknowledged no financial interest in any product or company mentioned herein. Dr. Kim may be reached at (919) 681-3568; terry.kim@duke.edu.
Roger F. Steinert, MD, is Professor and Vice Chair at the University of California, Irvine. He acknowledged no financial interest in any product or company mentioned herein. Dr. Steinert may be reached at (949) 824-8089; steinert@uci.edu.
1. The American Academy of Ophthalmology. Patient Safety Bulletin #2 Minimizing Wrong IOL Placement. June 14, 2005. Available at: http://www.aao.org. Accessed November 8, 2005.
Cataract Surgery | Jan 2006
Incorrect Lens Implant
Robert J. Arleo, MD, FACS; Francesco Carones, MD; Lisa Brothers Arbisser, MD; D. Matthew Bushley, MD; Terry Kim, MD; and Roger F. Steinert, MD
