Case study: Phacoemulsification handpieces (cataract surgery)

Background information

A number of Yellow Card reports have been received about particles found in the eye either during, or after cataract surgery. Investigation into these particles have found that they were from several sources, including: 

• Medical instruments 

• Packaging 

• Debris from previous surgery 

• crystallised fluids used during surgery 

Response

A project was undertaken to ensure manufacturers’ cleaning instructions to ensure up to date and included specific UK requirements. Additionally, work was undertaken with a manufacturer to redesign part of the equipment (medical device) to reduce the risk of plastic particles shedding during use. 

Following the work with manufacturers, additional information was issued to users of this equipment in a Device Safety Information document. This document highlighted the need to follow manufacturers’ cleaning instructions and have clear procedures and training to ensure risks were reduced. 

Result

Clearer instructions for cleaning and the issue is more widely known about. MHRA continues to monitor reports to ensure the safety of such products for patients and users of medical devices.

Return to the Yellow Card scheme case studies page or submit a report.