EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-16.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311323142), received between Sep 14, 2023 and Jul 29, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced low vault with rotation. The lens was repositioned, but repositioning did not resolve the problem. The lens was later exchanged for a longer length lens and the problem was resolved. Cause of the event is unknown.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50064255 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED RETINAL DETACHMENT. REPORTEDLY, "PATIENT EXPERIENCED RETINAL DETACHMENT ON LEFT EYE AND TREATMENT WAS DONE." THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 3 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438236 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOES. THE LENS WAS EXPLANTED. CAUSE OF THE EVENT IS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

  Patient problems: Halo

  MAUDE report 24582964 ↗
• InjuryJan 23, 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 REFRACTIVE SURPRISE. THE LENS WAS LATER EXCHANGED FOR A SAME SIZE AND MODEL, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

  Patient problems: Blurred Vision

  MAUDE report 21223393 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF A -16.0/2.0/095 WAS IMPLANTED BY THE SURGEON INTO THE PATIENT'S RIGHT EYE (OD). CONCOMITANT PRODUCT INFORMATION USED INTRAOPERATIVELY INCLUDING VISCOELASTIC AND DELIVERY SYSTEM TYPE WERE NOT PROVIDED. PER THE REPORTER, "ONE YEAR AFTER THE INITIAL SURGERY AND DAY 1 AFTER SURGERY TO INCREASE SPHERICAL POWER", TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PUPIL FIBRIN WAS OBSERVED. DIAGNOSTIC CULTURES WERE NOT PERFORMED BUT ANTIBIOTIC AND STEROID OPHTHALMIC DROPS AS WELL AS ORAL STEROIDS WERE PRESCRIBED. VISUAL ACUITY WAS NOTED AS OF (B)(6) 20224 TO BE IMPROVED FROM 1.0 (~20/20) TO 1.2 (~20/15). THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19102335 ↗
• InjuryJan 20, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -16.0/2.0/094 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548588 ↗
• MalfunctionOct 20, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -16.00/2.0/086 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). ON (B)(6) 2023 THE LENS WAS IMPLANTED AND REMOVED INTRA-OPERATIVELY DUE TO THE LENS BEING IMPLANTED UPSIDE DOWN. NO PATIENT INJURY REPORTED. A REPLACEMENT LENS OF THE SAME MODEL AND SIZE AND SIMILAR POWER WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971999 ↗
• MalfunctionOct 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -16.0/2.0/095 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS NOT IMPLANTED, BUT THERE WAS PATIENT CONTACT ON (B)(6) 2023 . ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865101 ↗
• InjurySep 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -16.0/2.0/092 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750914 ↗

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, Classified
  EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.