Mitigating Unintended Fiducial Markings in Non-Toric Intraocular Lenses: An Engineering Management Approach

Abstract

The Johnson & Johnson Vision plant in Añasco manufactures Non-Toric intraocular lenses (IOLs), which have recently experienced a recurring issue of unintended fiducial markings. These defects, if undetected, compromise product integrity, patient safety, and production efficiency. Root cause analysis determined human errors specifically incorrect machine programming selection as the primary contributor. To address this, an upgraded version of CNC Program Assembler software was developed to enforce correct program usage through barcode scanning, preventing operational oversights. Complementary procedural actions included operator training, standard operating procedure updates, and engineering test validations. A cost benefit analysis revealed substantial material and labor losses due to incorrect production, justifying the proposed corrective measures. The revised system enhances traceability, reduces waste, and ensures consistent quality. Ongoing monitoring and feedback collection are planned to ensure sustainable improvements and compliance. This initiative reflects a strategic integration of risk management, process optimization, and quality assurance to support continuous improvement.