EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.5/2.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542116671), received between Feb 4, 2023 and Aug 10, 2023 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -10.5/2.5/110 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED AS A REPLACEMENT LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023, DUE TO LENS TEAR. THE PROBLEM WAS RESOLVED. REPORTEDLY, "CORTICAL SPOKING ON LENS. DOING WELL OTHERWISE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17505814 ↗
• MalfunctionJun 9, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -10.50/2.5/109 TORE DURING LOADING. A REPLACEMENT LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099048 ↗
• InjuryMar 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -10.50/2.5/094 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE EYE OF A PATIENT WITH PRE-EXISTING GLAUCOMA ON (B)(6) 2022. PIGMENT DISPERSION AND IRITIS WERE OBSERVED. CAUSE OF THE EVENT IS BOTH A UNKNOWN AND A PATIENT RELATED FACTOR. REPORTEDLY, THE STATUS OF THE EYE IS, "MOSTLY QUIET" AND "TAPERING PREDNISOLONE INITIATED LATANOPROST IN MY OPINION BEST IRRESPECTIVE OF PIGMENT DISPERSION, IRITIS."

  Patient problems: Intraocular Pressure Increased; Iritis

  MAUDE report 16585378 ↗
• MalfunctionFeb 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -10.50/2.5/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. LENS ROTATION WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301928 ↗

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