Implantable collamer lenses recalled after being labeled with wrong length
Staar Surgical is recalling seven EVO+ Visian Toric Implantable Collamer Lenses that were labeled as 12.1 mm but are 12.6 mm, creating the potential for excessive vault.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: mislabelled lens length may cause a range of ocular complications, and no injuries are stated in the source.
Plain-English summary
Staar Surgical AG is recalling the EVO+ Visian Toric Implantable Collamer Lens (TICL), model VTICM5. Seven units were distributed internationally to India, Iran, Korea and Saudi Arabia. The FDA has classified this recall as Class II.
The lenses, intended for correction or reduction of myopia in phakic eyes with astigmatism, were labelled as 12.1 mm in length but are 12.6 mm lenses. This creates the potential for excessive vault, which may cause significant reduction of irido-corneal angles, significant shallowing of the anterior chamber, patient discomfort, elevated intraocular pressure or angle closure, an unreactive pupil, and lens exchange or removal.
Affected product carries UDI-DI 00840311304363, an expiration date of 2027-11-30, and serial numbers T2286964, T2286971, T2286973, T2286979, T2286980, T2286981 and T2286988.
Facilities can identify affected lenses by the model, UDI and serial numbers above, and may contact Staar Surgical AG for further information.
The recalled product
- Product
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Manufacturer
- Staar Surgical AG
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964
- T2286971
- T2286973
- T2286979
- T2286980
- T2286981
- T2286988
Distribution
Distribution scope not specified by the agency.
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