EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.0/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542116732), received between Jul 21, 2022 and Dec 4, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.00/2.0/072 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS EYE ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REMOVED AND A REPLACEMENT LENS WAS IMPLANTED OF LONGER LENGTH LENS DUE TO LOW VAULT. THE REPLACEMENT LENS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261639 ↗
• InjuryNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5 13.2, -11.0/2.0/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS OBSERVED WITH ROTATION. LENS WAS REPOSITIONED. THIS DID NOT RESOLVE THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129715 ↗
• InjuryMar 7, 2023Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0/2.0/93 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6)2023, THE LENS WAS REMOVED AND LATER REPLACED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, GLARE, AND HALOS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. REPORTEDLY, "DOING WELL HAPPY WITH VISION.".

  Patient problems: Halo

  MAUDE report 16499869 ↗
• MalfunctionJul 21, 2022Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM13.2; -11.00/2/109 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022 THE PATIENT EXPERIENCED EXCESSIVE VAULTING AND IT WAS NOTED "IRIS TINTED". INTRAOPERATIVELY THE SURGEON REMOVED AND REPLACED THE LENS WITH A SHORTER LENGTH LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND INDICATED "THE LENS WAS TOO VAULTED AS HE WAS ADJUSTING TO IT AT THAT TIME HE CHOSE TO GO A SMALLER SIZE AND THAT ONE FIT WELL."

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

  MAUDE report 15080946 ↗

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