Until recently, there have been few efforts to share information on real-world complications in ophthalmologic surgery to alert providers to potential pitfalls, as is common with other surgical specialties. NewYork-Presbyterian ophthalmological experts have published first-of-its-kind articles detailing adverse events associated with the medical devices used in three types of ophthalmologic surgery. These summaries, and several others in the works, draw on reports from the Manufacturer and User Facility Device Experience (MAUDE) database, one of the FDA’s tools for post-market surveillance of medical devices.
Below, study authors Sarah H. Van Tassel, MD, director of the glaucoma service at NewYork-Presbyterian and Weill Cornell Medicine, and Kyle Kovacs, MD, a retinal specialist at NewYork-Presbyterian and Weill Cornell Medicine, discuss their findings on adverse events and explain the importance of gathering such data.
An Information Gap
As we observed our own surgical complications and complications from referred patients, we recognized that the clinical trial experience doesn't necessarily mirror what happens in practice because clinical trials are done on patients with very narrow, on-label presentation of disease. And in the case of surgical devices and surgical instrumentation, there are expert surgeons operating in pristine conditions. Our series of articles came from our interest in finding a structured way to talk about real-world surgical experience that was more than just anecdotal.
We were interested in the rare complications that have nothing to do with problematic FDA approval or problematic surgical technique. In addition, our intent was not to point a finger at the companies, which have made tremendous products that are overwhelmingly safe, but to highlight these issues and how surgeons can best use them and get the most out of the devices while minimizing complications.
Key Findings
Vitrectomy Platforms
Of the 2,534 reports identified, the most commonly reported complications between January 2010 and November 2021 involved the vitrectomy probe (37.8%) and the central processing unit (14.5%). Vitrectomy probe issues were more prevalent with the Constellation and Stellaris while infusion issues were more common for the EVA.
We found that there are very real differences in the encountered adverse events from platform to platform. You would think that the same problems would be more likely with each type of vitrectomy console, and it's not. In fact, our data showed that the trocars for one platform were more prone to breaking during the surgery compared with other platforms.
Femtosecond Laser-Assisted Cataract Surgery (FLACS)
Between 2010 and 2020, 1,927 reports met inclusion criteria and revealed 2,704 complications:
- 1,115 capsule tears (41.2%), 329 of which required vitrectomy
- 372 instances of suction loss, 321 other capsulotomy-related complications
- 432 corneal or incisional complications
Rare complications included 54 reports of miosis, 16 reports of endophthalmitis, and 4 reports of toxic anterior segment syndrome.
Interestingly the number of events in the MAUDE database increased year-over-year between 2011 and 2017, peaking in 2017 at 303 events. After 2017, the number of complications seemed to be decreasing even though we know that the volume of surgery was going up. This may reflect a collective learning curve in the field.
Microinvasive Glaucoma Surgery (MIGS)
Between January 2009 and December 2019, there were 2,032 reports describing 3,451 adverse events The most reported adverse events for MIGS devices of any type were elevated intraocular pressure (409), device malposition (401), decreased vision (220), hyphema (205), and hypotony (176). Devices were also reported to be occluded (105), lost in the eye (69), explanted unrelated to malposition (121), touching the cornea (75), or touching the iris (37). One of the devices, CyPass, was withdrawn from in 2018 the market because of endothelial cell loss.
The most interesting finding is that the number of reports about the complication with CyPass preceding the voluntary withdrawal were minimal. However, after the withdrawal, physicians reported surgeries with that complication from before the device withdrawal, suggesting it had alerted them to the complication. This highlights the importance of gathering data on complications from large numbers of physicians. We need to work together as a field to achieve a high threshold for safety and for excellence.
Promoting Transparency
There are two unique things about ophthalmology compared to some of the other surgical specialties. One is that we don't have much of a culture of looking at morbidity and mortality like general surgeons do. Because of this, there's not a great forum for people to discuss surgical complications and lessons learned. The second thing that's unique is that we have the capacity to film 100% of our surgeries because all of them happen under a microscope, and virtually every microscope is equipped with the capacity to record. Despite this capability, not very many people are showing their surgical failures. These factors have made our work looking at complications associated with vitrectomy platforms, FLACS, and MIGS particularly unique and welcomed by our colleagues. Ophthalmological surgeons generally found it refreshing that we've highlighted some of the struggles that we all experience. Implicit in these articles is our interest in drawing attention to the existence of the MAUDE database because it is an important tool that we can all use in a meaningful way so that we can learn more about our collective experience and take better care of patients.
