EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-6.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840311307746), received between Feb 22, 2023 and Aug 28, 2026 — classified as 5 injuries, 3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced over/under correction. The lens was later exchanged for a same size lens, different power and the problem was resolved. There are multiple medical device reports associated with this patient. This report is 1 of 2 total reports. Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.

  Patient problems: Blurred Vision

  MAUDE report 50489423 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED BLURRED VISION AND REFRACTIVE SURPRISE. THE LENS EXCHANGE FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS OTHER.

  Patient problems: Blurred Vision

  MAUDE report 23795335 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS REFRACTIVE SURPRISE. THE LENS WAS LATER INTRAOPERATIVELY REMOVED AND REPLACED FOR A SAME SIZE, SAME MODEL, DIFFERENT SPHERE AND AXIS LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS A PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19765368 ↗
• MalfunctionApr 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -6.00/1.0/061 (SPHERE/CYLINDER/AXIS) LENS HAD A TEAR/BREAK BEFORE/DURING LOADING. THIS OCCURRED ON (B)(6)2024. THE LENS WAS NOT IMPLANTED. A REPLACEMENT LENS OF THE SAME MODEL/SIZE AND SIMILAR POWER WAS IMPLANTED ON AN UNKNOWN DATE AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217903 ↗
• MalfunctionApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM (B)(6) IMPLANTABLE COLLAMER LENS OF -6.00/1.0/084 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023 AS A REPLACEMENT LENS. A REFRACTION ISSUE WAS REPORTED, THE REPORTER STATED " ICL OFF TARGET". THE LENS REMAINS IMPLANTED. SEE MFR# 2023826-2024-01645 FOR INITIAL LENS.

  Patient problems: Blurred Vision

  MAUDE report 19113612 ↗
• InjuryOct 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_ 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -6.0/1.0/084(SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036033 ↗
• InjuryApr 4, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -6.0/1.0/76 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON 08-FEB-2023. ON 17-FEB-2023, THE LENS WAS REMOVED DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 16678779 ↗
• MalfunctionFeb 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -6.00/1.00/89 SPHERE/CYLINDER/AXIS) LENS TEAR/BREAK DURING LOADING. LENS TEAR DUE TO SNAGGING ON (B)(6)2022. THE LENS WAS NOT IMPLANTED INTO THE PATIENTS RIGHT EYE (OD). A REPLACEMENT LENS OF THE SAME MODEL/SIZE AND SIMILAR POWER WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16423023 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.