EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/4.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840311309573), received between May 10, 2023 and Sep 17, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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 WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS REPORT 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OF CONTRIBUTION OF THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OF PRODUCT. DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239038 ↗
• InjuryJan 22, 2024Off-Label Use; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Off-Label Use; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.5/+4.0/093 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND LENS ROTATION. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT INDICATE THE CAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558967 ↗
• MalfunctionMay 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -13.5/+4.0/93 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS THERE IS AN OILY SURFACE ON THE LENS, THERE IS NO PATIENT ISSUE WITH NO PLANS TO EXPLANT THE LENS. THE PATIENT IS HAPPY WITH VISION. LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906150 ↗

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