Monrovia, CA, United States
Staar Surgical Company recalls
1 recall recorded since 2018, most recently on 29 September 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 September 2023
- Reason
- Their is a potential that intraocular implant devices may not meet specifications.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0474-2024, Z-0467-2024, Z-0469-2024, Z-0466-2024, Z-0465-2024, Z-0473-2024, Z-0471-2024, Z-0468-2024, Z-0464-2024, Z-0472-2024, Z-0470-2024
- EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
- EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
- EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- and 3 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.