Home / Recalls / Staar Surgical Company / Z-0474-2024

Z-0474-2024 Class II Ongoing

Recalled by Staar Surgical Company — Monrovia, CA

Recall Details

Product Type
Devices
Report Date
December 13, 2023
Initiation Date
September 29, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 units

Product Description

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Reason for Recall

Their is a potential that intraocular implant devices may not meet specifications.

Distribution Pattern

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

Code Information

Serial/UDI: S1746728/ (01)00841542122023(11)221120(17)241031(21)S1746728; S1713542/ (01)00841542122030(11)221026(17)240930(21)S1713542; S1746725/ (01)00841542122016(11)221120(17)241031(21)S1746725; S1707067/ (01)00841542122016(11)221022(17)240930(21)S1707067; S1734035/ (01)00841542122047(11)221111(17)241031(21)S1734035; S1713494/ (01)00841542122030(11)221026(17)240930(21)S1713494; S1713551/ (01)00841542122030(11)221026(17)240930(21)S1713551; S1740887/ (01)00841542122047(11)221115(17)241031(21)S1740887; S1713505/ (01)00841542122030(11)221026(17)240930(21)S1713505

Other recalls by Staar Surgical Company

  • Z-1480-2026 Class II — EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 (January 21, 2026)
  • Z-0468-2024 Class II — EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. (September 29, 2023)
  • Z-0466-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. (September 29, 2023)
  • Z-0467-2024 Class II — EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. (September 29, 2023)
  • Z-0471-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular (September 29, 2023)
  • Z-0464-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. (September 29, 2023)
  • Z-0473-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular (September 29, 2023)
  • Z-0465-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. (September 29, 2023)
  • Z-0470-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular (September 29, 2023)
  • Z-0472-2024 Class II — EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocula (September 29, 2023)