EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/1.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00840311307777), received between Apr 17, 2023 and Feb 6, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HIGH VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE LENS WAS LATER REMOVED AND REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283735 ↗
• InjuryDec 12, 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 SIGNIFICANT PIGMENT DISPERSION. LENS EXPLANTED AND PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED UNKNOWN.

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

  MAUDE report 23795334 ↗
• InjuryApr 25, 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 TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND HYPOPYON. DIAGNOSTIC CULTURE PERFORMED. THE TREATMENT PERFORMED: EYE DROPS BETAMETHASONE SODIUM PHOSPHATE, MOXIFLOXACIN DICLOFENAC NA MEDICATION: PREDNISOLONE, FAMOTIDINE THE LENS EXPLANTED. THE PROBLEM WAS NOT RESOLVED. REPLACEMENT LENS SURGERY IS SCHEDULED TO TAKE PLACE ONCE THE PATIENT'S EYE HAS STABILIZED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Hypopyon; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21912341 ↗
• InjuryApr 25, 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 TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND HYPOPYON. DIAGNOSTIC CULTURE NOT PERFORMED. THE TREATMENT PERFORMED: STEROID EYE DROPS/ ORAL MEDICATION. LENS REMAINS IMPLANTED, AND THE PROBLEM WAS NOT RESOLVED. UNDER OBSERVATION BECAUSE THE PATIENT HAS BLURRED VISION AND CONTINUED PAIN. REPLACEMENT LENS SURGERY IS SCHEDULED TO TAKE PLACE ONCE THE PATIENT'S EYE HAS STABILIZED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision; Hypopyon; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21912340 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 EXCESSIVE VAULTING, WITH SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 21542679 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTS AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968753 ↗
• InjuryAug 6, 2024Adverse 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 EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. DUE TO EXCESSIVE VAULT, THE LENS WAS REMOVED AND REPLACED FOR A SHORTER LENGTH LENS. THE INCISION WAS ENLARGED AND ADDITIONAL SUTURES. THE PROBLEM WAS NOT RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924500 ↗
• MalfunctionMay 10, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -07.50/+1.0/112 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING LOW VAULTING AND THE SURGEON HAS DECIDED TO LEAVE THE LENS IN THE EYE. PATIENT WILL RETURN FOR FOLLOW-UP VISIT IN 5 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19292065 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5 IMPLANTABLE COLLAMER LENS OF POWER -7.50/1.0/009 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. OPEGAN OVD WAS USED INTRAOPERATIVELY. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED AND CONFIRMED BY OCT IMAGING. ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS WAS PERFORMED. FINAL PATIENT STATUS AND VISUAL ACUITY WERE NOT PROVIDED. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19072590 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -7.50/1.0/002 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6)2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT REFRACTIVE SURPRISE . THE EXCHANGE RESOLVED THE PROBLEM. CAUSE WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18871308 ↗
• InjuryFeb 5, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5/1.0/082 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024 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 18645453 ↗
• InjuryDec 7, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -7.5/1.0/080 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED. SURGICAL ADDITION OF NEW PL WAS PERFORMED. ON (B)(6)2 023, THE LENS WAS REMOVED AND SMALLER LENGTH LENS WAS IMPLANTED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288510 ↗
• InjuryOct 11, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -07.50/+1.0/006 (SPHERE/CYLINDER/AXIS) IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916954 ↗
• InjuryOct 2, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -7.50/1.0/002 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858004 ↗
• InjuryJul 31, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, VTICM5_12.6 -7.5/1.0/101 (SPHERE/CYINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. LOW VAULT WAS OBSERVED, LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431300 ↗
• InjuryApr 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -7.5/+10/75 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON(B0)(6) 2023. THE PATIENT EXPERIENCED LOW VAULTING. ON 20-MAR-2023 THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16757608 ↗

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