EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.0/1.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542115100), received between Dec 7, 2022 and Nov 14, 2023 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM, VTICM5 12.6, -10.0/1.0/111 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 14/AUG/2023. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED. THE LENS WAS REPOSITIONED ON 23/OCT/2023. THIS DID NOT RESOLVE THE PROBLEM. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129707 ↗
• MalfunctionOct 17, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM, VTICM5_12.6. -11.00/1.0/005 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD). THE LENS TORE/BROKE DURING INJECTION/DELIVER INTO THE EYE. THERE WAS PATIENT CONTACT(LENS TOUCHED THE EYE). NO PATIENT INJURY. THE BACK UP LENS WAS IMPLANTED INTRAOPERATIVLY. THIS RESOLVED THE PROBLEM. REPORTEDLY, SURGEON MAY HAVE CAUSED PROBLEM LOADING LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948878 ↗
• MalfunctionJun 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED, A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00/+1.0/085 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT COMPLAINED OF VITREOUS FLOATERS POST-OP. AND THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Vitreous Floaters

  MAUDE report 17200399 ↗
• MalfunctionFeb 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -11.00/1.0/092 (SPHERE/CYLINDER/AXIS) LENS WAS NOTICED TO BE TORN WHILE IN INJECTOR, NO PATIENT CONTACT. THE LENS WAS NOT IMPLANTED. A BACKUP LENS WAS SUCCESSFULLY IMPLANTED. CAUSE REPORTED AS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439814 ↗
• InjuryDec 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -11.0/1.0/092 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. EXCESSIVE VAULT WAS OBSERVED. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15937238 ↗

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-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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.