Adverse Incident Reporting for Ophthalmology

Notification of Intraocular lens defect

Defects in intraocular lens (IOL) have been observed from time to time. They include broken lens optic or haptic, cracks, lines, deposits or opacification on the surface of IOL and others. The consequence of IOL defects can be trivial if it is noted before implantation. After implantation, the defective IOLs may affect patients’ vision or cause persistent ocular inflammation, leading to the need for explanting the defective IOL. The operation to explant IOL can lead to further ocular complications.

Information on IOL defects is not readily available. Though incident reporting on defective devices and equipment is encouraged at the Ministry of Health (MOH), this does not involve ophthalmologists working in the university or private facilities.

Recently, one of the MOH hospitals reported that 5% of the patients implanted with a particular brand of IOL had significant IOL opacification. Following that incident, the Health Technology Assessment (HTA) Unit of MOH conducted a HTA on hydrophilic IOL and recommended a reporting system for eye care professionals to notify any IOL defect that they encounter. The National Eye Database administration responded to the advice and established an online reporting system. It is accessible by all eye care professionals in the country. The information gathered will be reviewed and necessary actions will be taken by relevant stakeholders to lessen adverse consequences. These relevant stakeholders include MOH Medical Device Bureau, MOH ophthalmology service, university with ophthalmology departments, Malaysian Society of Ophthalmology, as well as IOL distributors and manufactures. It is vital for all eye care professionals to report any incident of IOL defects. In this way, patients' safety will be ensured.