lioli IOL Delivery System
Received Jul 27, 2026 · Event occurred Jun 23, 2026
Report 1000635309-2026-00003 · MDR key 50005335
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Ast Products, Inc.Model number
LIOLI-24Lot number
GACM6011
Product problems
- Off-Label Use
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Corneal Edema
Narrative
Description of Event or Problem
Initial reporter stated that an implantable collamer lens was implanted upside down using manufacturer's device, lioli IOL Delivery System (Model: LIOLI-24). There was patient contact and patient injury. ICL scraped endothelium resulting in endothelial cell loss and corneal edema. Lens was implanted, removed and replaced intraoperatively and problem was resolved.
Additional Manufacturer Narrative
Batch records were analyzed and no abnormalities were found during review of production and inspection records of lioli IOL Delivery System, Model: LIOI-24, Lot GACM6011. Testing of device from the same lot/batch retained by the manufacturer was conducted. The delivery was successful, and no phenomena similar to the customer complaint was observed during testing.