EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-10.5/1.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311307838), received between Jul 20, 2023 and Jun 15, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (2 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A DIFFERENT POWER, MODEL BUT SAME LENGTH LENS. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 25512499 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LOW VAULT WITH ROTATION. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED AND REPLACED WITH A LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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 24640728 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED IRIS ATROPHY AND TRANSILLUMINATION. DUE TO IRIS ATROPHY AND TRANSILLUMINATION DR PRESCRIBED INTRACAMERAL MOXIFLOXACIN. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED

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

  MAUDE report 20656011 ↗
• MalfunctionJun 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -10.50/+1.0/072 (SPHERE/CYLINDER/AXIS), DURING THE SAME SURGERY DUE TO THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENT'S LEFT EYE (OS). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444740 ↗
• MalfunctionMar 27, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -10.5/1.0/003 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. INTRAOPERATIVELY THE LENS WAS REMOVED. ON THIS SAME DATE A REPLACEMENT LENS OF SHORTER LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989524 ↗
• MalfunctionMar 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED 12.6MM VTICM5_12.6; -10.5/1.0/093 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918796 ↗
• MalfunctionJan 26, 2024Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -10.5/1.0/071 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. REFRACTIVE SURPRISE IS OBSERVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18591888 ↗
• InjurySep 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY, "THE PATIENT HAS AN UNEXPTECTED HYPEROPIC OUTCOME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839066 ↗
• InjurySep 1, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -10.50/1.0/093 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, REFRACTIVE SURPRISE WAS OBSERVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 17671454 ↗
• MalfunctionJul 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -10.50/1.0/093 (SPHERE/CYLINDER/AXIS) TORE DURING LOADING. REPORTEDLY, "LENS TEAR DUE TO CATCHING ON INJECTOR" ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE(OS) AND THE PROBLEM WAS RESOLVED. REPORTEDLY, STATUS OF THE EYE IS, "NO PROBLEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358366 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.