EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.0/2.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840311312085), received between Aug 3, 2023 and Feb 24, 2026 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 24435655 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT, ELEVATED IOP & TIGHT ANGLE. DUE TO EXCESSIVE VAULT, ELEVATED IOP AND TIGHT ANGLE THE LENS WAS EXCHANGED FOR A SAME MODEL BUT SHORTER LENGTH LENS. CAUSE OF THE EVENT IS UNKNOWN.

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

  MAUDE report 24185397 ↗
• MalfunctionOct 29, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TORE/BROKE DURING INJECTION DELIVERY INTO THE EYE. THE LENS WAS REMOVED INTRAOPERATIVELY. CAUSE OF EVENT WAS REPORTED AS DEVICE. REPORTEDLY, DID NOT CAUSE ANY SPECIAL PROBLEMS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557094 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS. PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810605 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF -13.00/2.5/079 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024.THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833054 ↗
• InjuryMar 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -13.00/+2.5/094 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO LOW VAULTING. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820206 ↗
• InjuryJan 26, 2024Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF A -13.0/2.5/103 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED UPSIDE DOWN INTO THE RIGHT EYE (OD) OF A PATIENT WITH PRE-EXISTING PROGRESSIVE MYOPIA ON (B)(6) 2023. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED. THE PROBLEM WAS NOT RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY, "DURING THE PROCEDURE OF REMOVING THE LENSE, ONE OF ITS ENDS WAS TORN SO NO ATTEMPT WAS MADE TO IMPLANT IT AGAIN." THE PROBLEM WAS NOT RESOLVED. CONVENTIONAL TREATMENT WITH MOXIFLOXACIN AND DEXAMETASONE, WITH NO APPARANT DAMAGE WAS REPORTED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591880 ↗
• InjuryAug 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.0/+2.5/095 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453908 ↗

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