EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.0/2.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542114844), received between May 19, 2022 and Mar 26, 2024 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLMER LENS OF -9.00/2.0/093 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD). RESIDUAL REFRACTIVE SURPRISE WAS REPORTED. LENS POSSIBLY IMPLANTED UPSIDE DOWN. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 18984216 ↗
• InjuryFeb 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM, VTICM512.6, -9.0/2.0/114 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED. ON (B)(6) 2024 THE LENS WAS REPOSITIONED AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663641 ↗
• InjuryJun 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.00/+2.0/091 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17138218 ↗
• MalfunctionMay 19, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6; -9.00/2.0/085 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS DAMAGED DURING LOADING. THERE WAS NO PATIENT CONTACT. A BACK UP LENS WAS USED. THIS OCCURRED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14440684 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• 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.