EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-8.0/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542114691), received between May 17, 2023 and May 19, 2025 — classified as 3 injuries.

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.

• InjuryMay 19, 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 BLURRED VISION AND LENS ROTATION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/ LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 22045114 ↗
• InjuryDec 22, 2023Adverse 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_12.6 IMPLANTABLE COLLAMER LENS, -08.00/+1.5/093 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. AT 5 DAYS POST-OP, TOXIC ANTERIOR SEGMENT SYNDROME (TASS) (FIBRIN AND 3+ CELL) WAS OBSERVED. TAP FOR CULTURE WAS PERFORMED AND WAS NEGATIVE. PREDNISOLONE, MOXIFLOXACIN INJECTION AND BROMFENAC COMPOUND DROPS WERE ADMINISTERED. ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS WAS PERFORMED (A/C WASHOUT). PATIENT WAS STARTED ON MEDROL DOSE PACK. POST-OP THE PATIENT HAS EXCELLENT VISION AND IOP, WITH ONLY TRACE RESIDUAL INFLAMMATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Inflammation; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 18387531 ↗
• InjuryMay 17, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -8.0/1.5/094 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS IMPLANTED AND REMOVED FOR A SHORTER LENGTH LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950114 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.