Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Oct 1;21(7):460-466.
doi: 10.1097/PTS.0000000000001376. Epub 2025 Jun 9.

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

Joshua Ong  1 , Beth K Hansemann, Paul P Lee, Jennifer S Weizer
Affiliations

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

Joshua Ong et al. J Patient Saf. .

Abstract

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.

Keywords: cataract surgery; intraocular lens; root cause analysis; safety outcomes; safety protocol.

PubMed Disclaimer

Conflict of interest statement

The authors disclose no conflict of interest.

References

    1. Rossi T, Romano MR, Iannetta D, et al. Cataract surgery practice patterns worldwide: a survey. BMJ Open Ophthalmol. 2021;6:e000464.
    1. Hatch WV, Campbell Ede L, Bell CM, et al. Projecting the growth of cataract surgery during the next 25 years. Arch Ophthalmol. 2012;130:1479–1481.
    1. Loh HP, de Korne DF, Chee SP, et al. Reducing wrong intraocular lens implants in cataract surgery. Int J Health Care Qual Assur. 2017;30:492–505.
    1. Michelotti M, de Korne DF, Weizer JS, et al. Mapping standard ophthalmic outcome sets to metrics currently reported in eight eye hospitals. BMC Ophthalmol. 2017;17:269.
    1. DeRosier, Stalhandske E, Bagian JP, et al. Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety’s prospective risk analysis system. Jt Comm J Qual Improv. 2002;28:248–267; 09.

MeSH terms

LinkOut - more resources