EVO/EVO+VISIAN Implantable Collamer Lens recallZ-0466-2024 · Staar Surgical Company · initiated Sep 29, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Staar Surgical Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Their is a potential that intraocular implant devices may not meet specifications.
FDA root cause category: Software design (manufacturing process)
What the company is doing
On October 25, 2023, Staar Surgical issued a "Urgent: Medical Device Voluntary Recall" notification to affected consignees. Staar Surgical ask consignees to take the following actions: 1. Review your current inventory of STAAR EVO/EVO+ devices. 2. If any of the devices identified in the Medical Device Recall Return Response form have not already been implanted, please remove them from your inventory and quarantine the product. 3. Complete the Medical Device Recall Return Response form indicating if each device has been implanted or is in your possession. 4. Fax the form within 5 days upon receipt of this notification to: 1-800-952-4923 or email a pdf copy of the form to: [email protected]. 5. Return the EVO/EVO+ device(s) with the Medical Device Recall Return Response form to STAAR Surgical using the prepaid postage to the address identified in the attached Medical Device Recall Return Response form. 6. Apply the enclosed sticker/label "Attn: Recall Coordinator" to the outside of each ICL box being returned to STAAR Surgical. 7. Affected product and distribution information specific to your facility is contained in the Medical Device Recall Return Response Form
Recall details
- Recall number
- Z-0466-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 29, 2023
- Posted by the FDA
- Dec 1, 2023
- Recalling firm
- Staar Surgical Company
- Quantity
- 51 units
- Product code
- MTA
- FDA submissions
- P030016
- 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
Product description
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
Serial Number/UDI: S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405; S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843; S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482; S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360; S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652; S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367; S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265; S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309; S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419; S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618; S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641; S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701; S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801; S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411; S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798; S1724122/ (01)00841542119320(11)221102(17)241031(21)S1724122; S1721409/ (01)00841542119405(11)221031(17)240930(21)S1721409; S2043428/ (01)00841542119429(11)230706(17)250630(21)S2043428; S1746891/ (01)00841542119375(11)221120(17)241031(21)S1746891; S1765467/ (01)00841542119436(11)221205(17)241130(21)S1765467; S1765395/ (01)00841542119375(11)221205(17)241130(21)S1765395; S1721457/ (01)00841542119429(11)221031(17)240930(21)S1721457; S1721402/ (01)00841542119429(11)221031(17)240930(21)S1721402; S1721450/ (01)00841542119429(11)221031(17)240930(21)S1721450; S1733624/ (01)00841542119467(11)221111(17)241031(21)S1733624; S1733562/ (01)00841542119450(11)221111(17)241031(21)S1733562; S1876673/ (01)00841542119467(11)230313(17)250228(21)S1876673; S1765388/ (01)00841542119375(11)221205(17)241130(21)S1765388; S1729681/ (01)00841542119467(11)221107(17)241031(21)S1729681; S1746880/ (01)00841542119375(11)221120(17)241031(21)S1746880; S1721427/ (01)00841542119429(11)221031(17)240930(21)S1721427; S1721455/ (01)00841542119429(11)221031(17)240930(21)S1721455; S1729363/ (01)00841542119368(11)221107(17)241031(21)S1729363; S1957456/ (01)00841542119399(11)230515(17)250430(21)S1957456; S1721485/ (01)00841542119429(11)221031(17)240930(21)S1721485; S1876724/ (01)00841542119450(11)230313(17)250228(21)S1876724; S1718864/ (01)00841542119399(11)221030(17)240930(21)S1718864; S1875218/ (01)00841542119368(11)230312(17)250228(21)S1875218; S1746837/ (01)00841542119375(11)221120(17)241031(21)S1746837; S1721580/ (01)00841542119375(11)221031(17)240930(21)S1721580; S1721540/ (01)00841542119375(11)221031(17)240930(21)S1721540; S1729467/ (01)00841542119382(11)221107(17)241031(21)S1729467; S1765370/ (01)00841542119375(11)221205(17)241130(21)S1765370; S1765384/ (01)00841542119375(11)221205(17)241130(21)S1765384; S1878607/ (01)00841542119467(11)230316(17)250228(21)S1878607; S1724121/ (01)00841542119313(11)221102(17)241031(21)S1724121; S1746866/ (01)00841542119375(11)221120(17)241031(21)S1746866; S1733049/ (01)00841542119344(11)221110(17)241031(21)S1733049; S1729399/ (01)00841542119368(11)221107(17)241031(21)S1729399; S1669799/ (01)00841542119382(11)220922(17)240831(21)S1669799; S1721439/ (01)00841542119429(11)221031(17)240930(21)S1721439
Devices named in this recall
13 devices in the FDA device registry whose identifier appears in the recall's code information.
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall12 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall8 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-6.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall6 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-7.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
Product lines
Other devices under the same FDA submission
1,404 devices cleared under P030016 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall8 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-12.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-6.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall6 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-5.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-6.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-7.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-7.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93312).
- Z-0464-2024 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0465-2024 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0467-2024 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0468-2024 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- Z-0469-2024 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0470-2024 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
- Z-0471-2024 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
- Z-0472-2024 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
- Z-0473-2024 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
- Z-0474-2024 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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