EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.0/2.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00840311308408), received between Apr 5, 2023 and Sep 28, 2026 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 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 low vault and lens rotation. Lens repositioned. Lens exchanged with longer length lens. Problem 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. Cause of the event was reported as unknown.

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

  MAUDE report 50917663 ↗
• InjuryJun 18, 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. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25551643 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND VISUAL DISTURBANCES (TUNNEL VISION). THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. 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.

  Patient problems: Visual Disturbances

  MAUDE report 24216314 ↗
• InjuryNov 23, 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 AN OVER/UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/LENGTH, DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. REPORTEDLY, "LENS REPLACEMENT ACCORDING TO PATIENT'S VISION PREFERENCE". THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23627849 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, SHALLOW AC. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23459464 ↗
• InjuryJul 11, 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 DISSATISFACTION. REPORTEDLY, "THE PATIENT COMPLAINED OF A HEADACHE." THE LENS WAS LATER REMOVED. CAUSE OF THE EVENT WAS A PATIENT-RELATED-FACTOR. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486026 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE SURGEON REPORTS THE LENS ROTATED, THEN WAS REPOSITIONED THAT SAME DAY OF POSTOP, BUT THE LENS ROTATED BACK LATER AND INDUCED HYPEROPIA AND ASTIGMATISM. LENS REMAINS IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 21380149 ↗
• InjuryOct 17, 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 LOW VAULT WITH ROTATION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477722 ↗
• InjurySep 4, 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 REFRACTIVE SURRPISE AND REFRACTIVE CHANGE OVER TIME. DUE TO REFRACTIVE SURPRISE AND REFRACTIVE CHANGE OVERTIME, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SAME LENGTH LENS. THE PROBLEM WAS RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 20137551 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -11.0/2.0/091 (SPHERE/CYLINDER/AXIS), WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588203 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00/+2.0/091 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367355 ↗
• MalfunctionMay 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2024 A 12.6MM, VTICM5_12.6, -11.0/2.00/071 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE LEFT EYE (OS). THERE WAS NO PATIENT INJURY. INTRAOPERATIVELY THE LENS WAS REMOVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN, THE REPORTER STATED " I SEE A LARGE TEAR WHEN I INJECT THE IOL IN AC". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281816 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5 -11.00/+2.00/000 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. INFORMATION ABOUT CONCOMITANT PRODUCTS USED INCLUDING OVD AND DELIVERY SYSTEM WERE NOT PROVIDED. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PER THE LAST REPORT DATED (B)(6) 2024, NO INFORMATION IS PROVIDED THAT THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO LOSS OF VISUAL ACUITY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19276559 ↗
• MalfunctionMar 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO IMPLANT A 12.6MM VTICM5_12.6; -11/2/109 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024, THE LENS HAD TORE DURING INJECTION/DELIVERY. THERE WAS PATIENT CONTACT WITH NO PATIENT INJURY. THE LENS WAS NOT IMPLANTED. ON (B)(6) 2024 A REPLACEMENT LENS OF THE SAME 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 18965674 ↗
• InjurySep 25, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -11.0/2.0/092 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE REPORTER REPORTS EXCESSIVE VAULT AND STATES THAT THERE IS STILL RESIDUAL ASTIGMATISM, LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 17814804 ↗
• InjurySep 12, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6, -11.00/+2.0/83 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. IT WAS REPORTED THE PATIENT HAS REFRACTIVE SURPRISE. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 17733897 ↗
• InjuryAug 2, 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 -11.0/2.0/137 (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 17446536 ↗
• InjuryApr 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6 MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -11.5/2.0/078 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGED RESOLVED THE PROBLEM. CAUSE OF EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748683 ↗
• InjuryApr 5, 2023Inadequacy 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 -11.00/2.00/102 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE EXCHANGE RESOLVED THE PROBLEM. IN THE REPORTERS OPINION THE DEVICE WAS THE CAUSE OF THIS EVENT. "DEVICE TOO LARGE" WAS REPORTED FOR CAUSE DETAILS.

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

  MAUDE report 16683450 ↗

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-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.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.