CONFIDENTIAL DRAFT SUBJECT TO CHANGE OR DELETION
DRAFT DECLARATON REVISION OF SURGEON
6. The next verification of the intended intraocular lens (“IOL”) is performed during the surgical timeout with the circulating nurse and scrub nurse, during which the patient’s identity, the eye scheduled for surgery, and the intended IOL model and diopter power are verbally confirmed. An additional verification occurs when I request the IOL during the surgical procedure. At that time, the circulating nurse obtains the IOL and verifies its specifications with the scrub nurse before the scrub nurse loads the IOL into the inserter.
During this portion of the procedure, my attention is directed toward the patient’s operative eye through the surgical microscope. Maintaining visualization of the surgical field is an important part of my responsibility as the operating surgeon. Because I am engaged in the surgical procedure and viewing the operative field through the microscope, I am not simultaneously observing the circulating nurse’s retrieval and verification of the IOL or the scrub nurse’s subsequent loading of the IOL into the inserter. These activities occur outside my microscopic field of view. Accordingly, I rely upon the circulating nurse and scrub nurse to perform the established verification and loading functions.
7. The ZCU225 intraocular lens deployed in this case incorporates orientation markings for alignment of its toric axis to correct astigmatism but it does not have readily visible markings identifying its spherical diopter power on the lens itself. Once an IOL has been loaded into the inserter cartridge, the lens is enclosed within the cartridge in preparation for implantation. The cartridge limits direct visual access to the lens, and the IOL does not display identifying information to can confirm its specific model and diopter power.
8. Based upon my preoperative verification of the ordered IOL, the established surgical verification and loading procedure, and my reliance upon the circulating nurse and scrub nurse to perform their respective responsibilities, I believed at the time of surgery on August 10, 2023, that I had implanted the intended ZCU225 +14.0 diopter lens, as documented in my operative report. I learned the following day that the IOL implanted was not the lens that had been selected and ordered for Mr. Janis. Upon learning of this discrepancy, I promptly notified Mr. Janis and advised him of the need for an IOL exchange procedure.