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 |
| Recall / campaign no. | UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
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.
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.