EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
USEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Recalling Firm: Staar Surgical AG
Motif du rappel / Danger
TranslatedToric 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.
Description du produit & Identification
TranslatedEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Additional Source Details
| Field | Value |
|---|---|
| City | Nidau |
| State | N/A |
| Event id | 98397 |
| Address 1 | Haupt Strasse 104 |
| Address 2 | N/A |
| Code info | UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 |
| Postal code | N/A |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 7 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260121 |
| Initial firm notification | N/A |
| Center classification date | 20260302 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Aperçu
- Entreprise responsableStaar Surgical AG
- StatusOngoing
- Niveau de risqueClass II
- DistributionInternational distribution to the countries of India, Iran, Korea, Saudi Arabia.
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🚨 SAFETY ALERT: Staar Surgical AG - EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 Check if your household is affected: https://therecallfile.com/fr/recalls/evo-visian-toric-implantable-collamer-lens-ticl-model-vticm5/FDA-Z-1480-2026
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