EVO/EVO+VISIAN Implantable Collamer Lens
Received Jul 29, 2026 · Event occurred Feb 15, 2026
Report 2023826-2026-01359 · MDR key 50064255
Device
Generic name
Phakic Toric Intraocular Lens
Manufacturer
Staar Surgical CompanyModel number
VTICMO_12.6 (-16.0/2.0)Catalog number
VTICMO_12.6
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced low vault with rotation. The lens was repositioned, but repositioning did not resolve the problem. The lens was later exchanged for a longer length lens and the problem was resolved. Cause of the event is unknown.
Additional Manufacturer Narrative
H6: 4581:Lens rotation.(b)(4)-Lens work order search: No similar complaints within associated lots were found. Manufacture Narrative:Secondary surgical intervention to rotate, remove, and replace the lens are identified in the labeling as a known potential adverse event following ICL implantation.Claim# (b)(4).