EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-3.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542119047), received between Feb 21, 2023 and Dec 13, 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.

• MalfunctionDec 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -03.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS INDICATED THAT THERE IS A PLANNED LENS EXCHANGE. 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 18322984 ↗
• MalfunctionDec 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -03.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS INDICATED THAT THERE IS A PLANNED LENS EXCHANGE. 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 18322982 ↗
• InjuryFeb 21, 2023Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -3.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDO CORNEAL ANGLES. EYE 'ACHE' DUE TO CILIARY BODY COMPRESSION WAS OBSERVED. ON (B)(6) 2023 THE LENS WAS REMOVED AND ON THE SAME DAY DIFFERENT SURGERY A REPLACEMENT LENS OF SHORTER LENGTH LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS PATIENT RELATED FACTOR; DEVICE DID NOT FAIL TO PERFORM AS INTENDED.

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

  MAUDE report 16413989 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.