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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Staar Surgical Company: EVO Visian Implantable Lenses Recalled for Not Meeting Specifications

Agency Publication Date: December 1, 2023
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Summary

Staar Surgical Company is recalling 252 units of various EVO Visian and EVO+ Visian Implantable Collamer Lenses (ICL), which are used during eye surgery to correct vision. These intraocular implant devices may not meet the necessary technical specifications required for safe use. This voluntary recall includes several models of Phakic and Phakic Toric lenses distributed across 38 U.S. states between late 2022 and mid-2023. Consumers should verify if their specific implant is affected by reviewing the serial and model numbers with their eye surgeon or clinic.

Risk

If an intraocular lens does not meet its manufacturing specifications, it may lead to improper vision correction or other medical complications following eye surgery. While no specific injuries were mentioned in the recall, the deviation from set standards poses a risk to patient safety during and after the implantation procedure.

What You Should Do

  1. Identify if you have received a Staar Surgical implant by checking your surgical records or contacting the eye clinic where your procedure was performed.
  2. Check your device information against the affected model numbers (REF), including VICM5_12.1, VICM5_12.6, VICM5_13.2, VICM5_13.7, VICMO12.1, VICMO12.6, VICMO13.2, VTICM5_12.1, VTICM5_12.6, VTICM5_13.2, and VTICM5_13.7.
  3. Verify the serial number or UDI on your patient identification card or surgical records; examples include serial numbers starting with S1894967, S1954863, T1366733, or T1210975.
  4. If you have an affected lens and have not yet had surgery, do not proceed with the implantation and ensure the medical facility returns the product to the manufacturer.
  5. If you have already had the lens implanted, contact your ophthalmologist or healthcare provider to discuss the recall and determine if any additional follow-up care or monitoring is necessary.
  6. Contact Staar Surgical Company at 1911 Walker Ave, Monrovia, California, or call their customer service for more information regarding this recall.
  7. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare and Manufacturer Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: EVO+VISIAN Implantable Collamer Lens (REF:VICM5_12.1)
Model / REF:
VICM5_12.1
Lot Numbers:
S1894967
S1954863
S1725689
S1725624
S1771602
S1725625
S1847793
S1725627
S1901889
S1771554
S1699274
S1877126
S1771633
S1744475
S1863018
S1734365
S1877112
S1901884
S1725691
S1892278
Product: EVO+VISIAN Implantable Collamer Lens (REF: VICM5_12.6)
Model / REF:
VICM5_12.6
Lot Numbers (133):
S1731386
S1767226
S1829207
S1731401
S1731432
S1743481
S1767274
S1752570
S1743474
S1731493
S1752526
S1752533
S1752529
S1732703
S1767229
S1832551
S1743500
S1731502
S1752370
S1731407
S1767262
S1731477
S1731483
S1731391
S1767278
S1752513
S1882887
S1868138
S1767235
S1752520
S1731469
S1866689
S1731459
S1752601
S1945398
S1752585
S1732727
S1731463
S1731404
S1731497
S1743504
S1767232
S1829172
S1752348
S1829156
S1732741
S1731473
S1752554
S1752558
S1752548
Product: EVO+VISIAN Implantable Collamer Lens (REF: VICM5_13.2)
Model / REF:
VICM5_13.2
Lot Numbers (51):
S1721405
S1746843
S1721482
S1765360
S1957652
S1765367
S1879265
S1855309
S1721419
S1749618
S1758641
S1957701
S1760801
S1765411
S1669798
S1724122
S1721409
S2043428
S1746891
S1765467
S1765395
S1721457
S1721402
S1721450
S1733624
S1733562
S1876673
S1765388
S1729681
S1746880
S1721427
S1721455
S1729363
S1957456
S1721485
S1876724
S1718864
S1875218
S1746837
S1721580
S1721540
S1729467
S1765370
S1765384
S1878607
S1724121
S1746866
S1733049
S1729399
S1669799
Product: EVO+VISIAN Implantable Collamer Lens (REF: VICM5_13.7)
Model / REF:
VICM5_13.7
Lot Numbers:
S1721962
Product: EVO VISIAN Implantable Collamer Lens (REF: VICMO12.1)
Model / REF:
VICMO12.1
Lot Numbers:
S1734493
Product: EVO VISIAN Implantable Collamer Lens (REF: VICMO13.2)
Model / REF:
VICMO13.2
Lot Numbers:
S1723954
S1723955
Product: EVO+VISIAN Implantable Toric Lens (REF: VTICM5_12.1)
Model / REF:
VTICM5_12.1
Lot Numbers:
T1366733
T1485721
T1347685
Product: EVO+VISIAN Implantable Toric Lens (REF: VTICM5_12.6)
Model / REF:
VTICM5_12.6
Lot Numbers:
T1210975
T1283082
T1359541
T1377771
T1443561
T1226995
T1365648
T1255982
T1555552
T1187773
T1235414
T1210808
T1195554
T1373152
T1566889
Product: EVO+VISIAN Implantable Toric Lens (REF: VTICM5_13.2)
Model / REF:
VTICM5_13.2
Lot Numbers:
T1307122
T1485436
T1257531
T1365550
T1511722
T1187957
T1342243
T1367644
T1205475
T1387400
T1228382
Product: EVO+VISIAN Implantable Toric Lens (REF: VTICM5_13.7)
Model / REF:
VTICM5_13.7
Lot Numbers:
T1438478
T1224985
T1259704
T1370322
T1508546
T1299195
Product: EVO VISIAN Implantable Collamer Lens (REF: VICMO12.6)
Model / REF:
VICMO12.6
Lot Numbers:
S1746728
S1713542
S1746725
S1707067
S1734035
S1713494
S1713551
S1740887
S1713505

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93312
Status: Active
Manufacturer: Staar Surgical Company
Sold By: Authorized ophthalmology clinics; specialty eye surgery centers
Manufactured In: United States
Units Affected: 11 products (20 units; 133 units; 51 units; 1 unit; 1 UNIT; 2 units; 3 units; 15 UNITS; 11 UNITS; 6 UNITS; 9 units)
Distributed To: Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.