EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-12.0/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542116855), received between Mar 30, 2023 and May 18, 2023 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.00/1.0/014 (SPHERE/CYLINDER/AXIS), TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT IS DOING WELL AND HAPPY WITH VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956397 ↗
• MalfunctionMay 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.00/+1.0/016 (SPHERE/CYLINDER/AXIS), TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE LENS WAS DISCARDED. THE PATIENT IS DOING WELL AND HAPPY WITH VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16922077 ↗
• InjuryMar 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -12.0/1.0/078 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2023. THE LENS WAS REMOVED AND LATER REPLACED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644900 ↗

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-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-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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.