Staar Surgical Company Recall 93312
Description: EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Staar Surgical Company Recall 93312 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0474-2024 |
| Event ID | 93312 |
| Event Description | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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 | 9 units |
| Recall Reason | Their is a potential that intraocular implant devices may not meet specifications. |
| Device Classification | 20231213 |
| Device Code Info | 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 |
| Center Classification Date | 20231201 |
| Recall Initiation Date | 20230929 |
| Recalling Firm | Staar Surgical Company |
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