EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-16.5/1.0) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311326754), received between Feb 23, 2023 and Jun 17, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Adverse 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. SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND SHALLOWING OF THE AC. BLURRED VISION. REPORTEDLY, 'HYPEROPIC ERROR DUE TO ANTERIOR POSITIONING.' IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A SHORTER LENGTH AND PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25540895 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED AN EXCESSIVE VAULT. SURGICAL PI WAS PERFORMED. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24526479 ↗
• InjuryDec 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 AN EXCESSIVE VAULT AND IRIDO-CORNEAL TOUCH. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860436 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS -16.50/+1.00/076 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT`S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024, INFLAMMATION WAS DIAGNOSED (EYE WAS RED AND PAINFUL). ADDITIONAL DIAGNOSTICS WERE PERFORMED SUCH AS MACULAR OCT AND VITREOUS CULTURES (NEGATIVE). SUBSEQUENT TREATMENTS WERE: AC WASHOUT, RETINA SURGEONS INJECTED ANTIBIOTICS. WITH PRESCRIPTION OF ADDITIONAL STEROIDS AND ANTIBIOTICS, BY ON (B)(6) 2024 ISSUES RESOLVED, THE EYE WAS WHITE AND QUIET, NEGATIVE SEIDEL TEST. ACCORDING TO THE SURGEON THE CAUSE OF THE EVENT WAS DUE TO A MEDICAL TRAUMA, DIFFICULT CASE; THE PUPIL WOULD NOT DILATE AND THE IRIS WAS MANIPULATED MORE THAN NORMAL. THE SURGEON INDICATES THIS WAS A CASE OF INFLAMMATION AND NOT INFECTION. THE LAST INFORMATION OBTAINED ON (B)(6) 2024 STATED THAT PATIENT CURRENT POST-OP PROTOCOL WAS PRED-MOXI-BROM TWICE A DAY. THE LENS REMAINS IMPLANTED.

  Patient problems: Eye Pain; Inflammation; Red Eye(s)

  MAUDE report 18602467 ↗
• InjuryMay 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -16.50/+1.0/083 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO EXCESSIVE VAULT. IN A SEPARATE SURGERY THAT DAY A SHORTER LENGTH LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027931 ↗
• InjuryFeb 23, 2023Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2; -16.5/1.0/074 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON REPORTS THE PATIENT EXPERIENCED EXCESSIVE VAULTING; SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES; ANGLE CLOSURE WITH ELEVATED INTRAOCULAR PRESSURE; HEADACHES; SHALLOW ANTERIOR CHAMBER. ON (B)(6) 2023 THE LENS WAS EXPLANTED. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND A PATIENT RELATED FACTOR AND NOTED "PATIENT HAS EXTREME FLOPPY IRIS WHICH IS CAUSING EXTREME BOWING OF IRIS TISSUE FORWARDS LEADING TO REDUCTION OF IRIDOCORNEAL ANGLE; LEFT EYE WORSE THAN RIGHT. IOP SPIKES PRESENT CAUSING HEADACHE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Headache; Intraocular Pressure Increased

  MAUDE report 16433012 ↗

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