Staar Surgical Company: Medical Device Recall in 2023 - (Recall #: Z-0469-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Product Classification:

Class II

Date Initiated: September 29, 2023

Date Posted: December 13, 2023

Recall Number: Z-0469-2024

Event ID: 93312

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2 units

Code Information:

Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;

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

Voluntary or Mandated:

Voluntary: Firm initiated