Lenses Recall: STAAR EVO+ Visian Toric TICL VTICM5
The recall concerns EVO+ Visian Toric Implantable Collamer Lenses due to a labeling length discrepancy where lenses labeled 12.1 mm are actually 12.6 mm, potentially causing excessive vault. Potential complications include significant reduction of irido-corneal angles, shallowing of the anterior chamber, patient discomfort, elevated IOP/angle closure, an unreactive pupil, and possible need for lens exchange or removal. Seven units were distributed internationally to India, Iran, Korea, and Saudi Arabia; the recall is associated with FDA under UDI-DI 00840311304363 with expiration 2027-11-30.
| Brand | Staar Surgical AG |
|---|---|
| Product | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 |
| Reason | Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal. |
| Severity | moderate |
| Units affected | 543 |
| Distribution | International distribution to the countries of India, Iran, Korea, Saudi Arabia. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Contact your eye care professional to determine if your EVO+ Visian Toric TICL VTICM5 lens is affected and discuss monitoring or corrective action.
- Schedule an eye exam to assess vault, anterior chamber depth, irido-corneal angles, and intraocular pressure.
- Do not attempt to remove or modify the lens yourself; follow your clinician's instructions.
- For more information, visit the FDA recall page or contact STAAR for guidance.
How to identify the recalled item
| Lot / date codes | UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
|---|---|
| Lot / date codes | Lot Code: UDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.