EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.0/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542114837), received between Sep 27, 2022 and Jan 10, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2023. ON (B)(6) 2023, LENS ROTATION WAS OBSERVED. ON (B)(6) 2023, THE LENS WAS REMOVED AND REPLACED FOR A LONGER LENGTH LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486438 ↗
• MalfunctionSep 27, 2022Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE THE SURGEON ATTEMPTED TO IMPLANT A 12.6MM VTICMO12.6; -9.0/1.5/123 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) THE LENS TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT WITH NO PATIENT INJURY. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME LENGTH/MODEL. THIS OCCURRED ON (B)(6) 2022. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR WITH DEVICE CAUSALITY; IT WAS NOTED "WHEN TRYING TO FIX PLACEMENT BEGAN TO BRING IT OUT TO REINSERT IT AND IT TORE; THEN PLACED BACK UP LENS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491969 ↗

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