Adverse Events Associated With 3 Vitrectomy Platforms Reported to the US FDA MAUDE Database.

Area of Science:

• Ophthalmology
• Medical device safety
• Surgical technology

Background:

• Vitrectomy surgery is a common ophthalmic procedure.
• Real-world data provides valuable insights into medical device performance and safety.
• Adverse events (AEs) associated with surgical equipment can impact patient outcomes.

Purpose of the Study:

• To identify and describe adverse events (AEs) associated with three vitrectomy platforms: Constellation, EVA, and Stellaris.
• To analyze the types and prevalence of device-specific complications reported in real-world use.
• To compare the AE profiles across the three vitrectomy platforms.

Main Methods:

• Analysis of 2534 reports from the US Food and Drug Administration's MAUDE database (January 2010 - November 2021).
• Inclusion of reports related to Constellation, EVA, and Stellaris vitrectomy platforms.
• Exclusion of duplicate or inadequately described reports, followed by descriptive analysis of AE prevalence.

Main Results:

• Vitrectomy probe issues were the most common overall complications (37.8%), followed by central processing unit issues (14.5%).
• Constellation and Stellaris platforms predominantly reported vitrectomy probe issues, while the EVA platform reported more infusion issues.
• Infusion issues led to patient harm most frequently with the Constellation (1.8%) and EVA (6.0%) platforms.

Conclusions:

• Real-world data from the MAUDE database highlights device-specific AEs relevant to ophthalmic surgical practice.
• Familiarity with potential complications of vitrectomy platforms is essential for minimizing patient harm.
• Continuous monitoring and analysis of device performance are critical for enhancing surgical safety.