EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-16.5/1.5) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542121149), received between Sep 16, 2022 and Jan 29, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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.

• 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/+1.50/105 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT`S RIGHT EYE (OD) ON (B)(6) 2023. ON THE (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 (B)(6) 2024 ISSUES RESOLVED, 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 23-JAN-2024 WAS STATING 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 18602470 ↗
• MalfunctionMay 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -16.50/+1.5/008 (SPHERE/CYLINDER/AXIS), WAS REPORTED AS "APPEARS TO BE FAULTY". THE LENS WAS NOT USED AND THE BACKUP LENS WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998311 ↗
• InjuryMar 7, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF -16.5/1.5/087 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S EYE. EXCESSIVE VAULTING IS OBSERVED AND A EXCHANGE IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499867 ↗
• MalfunctionSep 16, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A PATIENT WHO HAD AN IMPLANTABLE COLLAMER LENS IMPLANTED ON (B)(6) 2022 EXPERIENCED A -6D MYOPIC SHIFT AT HIS 1 DAY POST-OP VISIT. PER UPDATED INFORMATION THE REPORTER STATES " THE PATIENT RETURNED FOR HIS 1 WK POST OP CHECK TODAY WITH PLANO REFRACTION AND PERFECT VISION. THERE IS NO ISSUE AT THIS TIME. I BELIEVE THE 1 DAY MYOPIC SHIFT SEEN ON EXAM WAS DUE TO USE OF MIOSTAT DURING SURGERY AND THIS EFFECT HAS RESOLVED". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

  Patient problems: Blurred Vision

  MAUDE report 15440641 ↗

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-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-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.
• 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.