Staar Surgical Company Recall 93312
Description: EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Staar Surgical Company Recall 93312 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0469-2024 |
| Event ID | 93312 |
| Event Description | EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. |
| Product Type | Devices |
| 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 |
| Quantity | 2 units |
| Recall Reason | Their is a potential that intraocular implant devices may not meet specifications. |
| Device Classification | 20231213 |
| Device Code Info | Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955; |
| Center Classification Date | 20231201 |
| Recall Initiation Date | 20230929 |
| Recalling Firm | Staar Surgical Company |
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