EVO/EVO + VISIAN Implantable Collamer Lens (ICL)
Received Jul 29, 2026 · Event occurred May 18, 2026
Report 2023826-2026-01401 · MDR key 50072852
Device
Generic name
Phakic Toric Intraocular Lens
Manufacturer
Staar Surgical CompanyModel number
VTICMO 13.2 (-13.50/ 4.5)Catalog number
VTICMO 13.2
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Iritis
- Uveitis
Narrative
Description of Event or Problem
A Facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced a Uveitis/Iritis. Treatment was performed. The lens remains implanted and the problem resolved. The cause of the event was reported as unknown.
Additional Manufacturer Narrative
H6- Investigation Type Code (B): 4110- Lens Work Order Search-No Similar Complaint event(s) within associated lots were found. H6. Health Effect- Impact code (F): 4625- Treatment performed. H11- Manufacturer Narrative: Uveitis/Iritis is identified in the labeling as a known potential adverse event following ICL implantation. Iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen. In some cases, the degree of inflammation may be more severe and require extended steroid treatment. Procedural factors including excessive surgical manipulation and the use of pro-inflammatory substances in the eye may have contributed to the event. Mechanical insult to the iris can result in a prolonged or stronger inflammatory response. An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors. Claim# (b)(4).