CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
EVO+Visian Implantable Collamer Lens recalled by Staar Surgical
Staar Surgical is recalling EVO+Visian Implantable Collamer Lens, distributed in 32 states. The recall was initiated on 29 Sep 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0464-2024
- FDA event ID
- 93312
- Recalling firm
- Staar Surgical, Monrovia, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2023
- FDA classified
- 1 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Contact Lenses & Eye Devices
Timeline
| 29 Sep 2023 | Recall initiated by company | |
| 1 Dec 2023 | Classified by FDA | +63 days |
| 13 Dec 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is a potential that intraocular implant devices may not meet specifications.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Where it was distributed
US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNorth DakotaNebraska
Questions about this recall
Why was it recalled?
Their is a potential that intraocular implant devices may not meet specifications.
Which lots are affected?
Serial/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967; S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863; S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689; S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624; S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602; S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625; S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793; S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627; S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889; S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554; S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274; S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126; S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633; S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475; S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018; S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365; S1877112/(01)00841542118965(11)230313(17)250228(21)S1877112; S1901884/(01)00841542118873(11)230404(17)250331(21)S1901884; S1725691/(01)00841542118910(11)221103(17)241031(21)S1725691; S1892278/(01)00841542118897(11)230328(17)250228(21)S1892278
Where was it sold?
US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 93312This product is part of a recall event; the main page for the event is EVO Visian Implantable Collamer Lens recalled by Staar Surgical.
More recalls from Staar Surgical
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
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