Safety Outcomes Following Implementation of a Systematic Cataract Surgery Protocol at a Tertiary Referral Eye Center

Purpose: To evaluate the longitudinal safety outcomes of incorrect intraocular lens (IOL) implantation using a standardized cataract surgery operating standard operating procedure (SOP) devised at a tertiary referral eye center. This evaluation represents a critical but underrepresented topic in ophthalmic literature. Methods: This was a quality improvement, retrospective analysis, and description of the Healthcare Failure Mode Effect and Analysis (HFMEA) and resultant SOP implemented in 2018 following incorrect IOL events. Analysis of subsequent safety events following implementation of the SOP and modifications/reassessments performed was analyzed. The main outcome measures were processes identified in the HFMEA and incorrect IOL safety events occurring following implementation of the SOP. Results: The HFMEA identified 170 processes/subprocesses steps, 177 potential failure modes, and 75 potential failure mode causes. Twenty-nine system vulnerabilities were identified through analysis of the failure mode causes. From 2018 to 2023, 8 additional incorrect IOL safety events occurred, which led to subsequent revisions of the SOP. Conclusion: Continuous reassessment of standardized protocols for cataract surgery is critical to ensure patient safety.