EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.0/2.5) (REF VTICM5 12.6)Recalls & reported problems
Staar Surgical Company · VTICM5 - Diopter: -9.0; Cylinder 2.5; Overall Diameter (Length): 12.6 · Class 3 · Implant
All models of EVO/EVO+VISIAN Implantable Collamer Lens (1030)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840311308644), received between Apr 8, 2024 and Jun 18, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
8 other recalls cover devices cleared under the same FDA submission (P030016); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION. REPOSITIONING WAS ATTEMPTED. LENS REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22286755 ↗InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -9.00/+2.50/92 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. ON (B)(6) 2024 THE LENS WAS EXPLANTED. ON (B)(6) 2024 A REPLACEMENT LENS OF THE SAME LENGTH BUT DIFFERENT POWER WAS IMPLANTED AND THIS RESOLVED THE PROBLEM.
Patient problems: Blurred Vision
MAUDE report 19264052 ↗InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -9.00/2.5/088 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. LENS ROTATION WAS OBSERVED. THE LENS WAS REPOSITIONED ON (B)(6) 2023 AND THIS DID NOT RESOLVE THE PROBLEM. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SPHERICAL LENS MODEL OF THE SAME SIZE. THE REPLACEMENT LENS RESOLVED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19068443 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P030016. One submission often covers many models, so check the product and lot details in each record.
- Z-1480-2026 · Jan 21, 2026 · Open, ClassifiedEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Other Phakic Toric Intraocular Lens devices
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.0/1.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/1.5)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-8.5/2.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-5.0/1.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.5/2.5)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-14.0/2.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.5/1.5)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/1.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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