EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.0/1.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840311307807), received between Feb 21, 2023 and Aug 25, 2026 — classified as 15 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  A Facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced an excessive vault and over/ under correction. In a separate surgery the lens was exchanged with a shorter/spherical lens and the problem was resolved. Reportedly, 'the astigmatism was slightly overcorrected, so the lens was exchanged for a spherical lens'. The cause of the event was report 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50436858 ↗
• InjuryDec 11, 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 BLURRED VISION. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 23783794 ↗
• InjuryNov 24, 2025Adverse 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 A LOW VAULT WITH ROTATION. THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS OF A DIFFERENT DIOPTER. CAUSE OF THE EVENT LISTED AS PATIENT RELATED FACTOR "LACK OF 100% TICL SIZE PREDICTION." 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635552 ↗
• InjuryNov 21, 2025Adverse 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 A LENS ROTATION. THE LENS WAS REPOSITIONED & REMAINS IMPLANTED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624936 ↗
• InjuryOct 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 LOW VAULT AND REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A DIFFERENT DIOPTER LENS OF A LONGER LENGTH AND THE PROBLEM 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: Blurred Vision

  MAUDE report 23372265 ↗
• InjuryAug 6, 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 LENS ROTATION AND BLURRED VISION. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL, LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR.

  Patient problems: Blurred Vision

  MAUDE report 22734330 ↗
• MalfunctionNov 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACULTY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS HAD ZERO VAULTING. PLANNED LENS REMOVAL AND REPLACEMENT. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE 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 20768046 ↗
• InjuryAug 22, 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, LENS OPACITY (ASC). THE LENS REMAINS IMPLANTED WITH PLANNED EXCHANGE. 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 20029073 ↗
• InjuryAug 9, 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED WITH THE SAME MODEL/ LENGTH, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND THE DEVICE FAILED TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "THE EXPECTED SEQ FROM OCOS LENS CALCULATION WAS -00.01 WITH EXPECTED ASTIGMATISM OF +00.10. HOWEVER, PATIENTS POST-OP REFRACTION WAS PLANO -1.25X10. HENCE, PATIENT REPORTED BLUR DISTANCE VISION".

  Patient problems: Blurred Vision

  MAUDE report 19951407 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT THE FOLLOWING IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, LENS REPEATEDLY ROTATED. A LENS REMOVAL IS PLANNED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706824 ↗
• MalfunctionJul 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FACILITY REPRESENTATIVE REPORTED DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. A REPLACEMENT LENS OF THE SAME PARAMETERS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19693241 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AN ICL IMPLANTABLE COLLAMER LENS, INTO THE PATIENTS RIGHT EYE (OD). IT WAS REPORTED THE PATIENT EXPERIENCED ENDOTHELIAL CELL LOSS AND THE LENS REMAINED IMPLANTED. THE PATIENTS VISION IS EXCELLENT , WITH VERY SATISFACTORY REFRACTIVE OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Corneal Endothelial Cell Loss

  MAUDE report 18725200 ↗
• InjuryDec 15, 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 -9.00/+1.0/135 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT. THAT SAME DAY A SHORTER LENGTH LENS WAS IMPLANTED HOWEVER IT IS UNCLEAR IF THIS WAS PERFORMED INTRAOPERATIVELY. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336978 ↗
• InjuryNov 2, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -9.00/1.0/154 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT; LENS ROTATION; PIGMENT DISPERSION; BLURRED VISION AND UNREACTIVE (FIXED) PUPIL WAS REPORTED. ON (B)(6) 2023 THE LENS WAS REPOSITIONED AND THIS DID NOT RESOLVE THE PROBLEM. ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS WAS PERFORMED. PATIENT IS ON OPHTHALMIC MEDICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Discomfort; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 18060314 ↗
• MalfunctionOct 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 OF -9.00/1.0/095 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS TORE/BROKE DURING LOADING ON (B)(6) 2023. THE LENS WAS NOT IMPLANTED INTO THE PATIENTS LEFT EYE (OS). A REPLACEMENT LENS OF THE SAME MODEL/SIZE AND POWER WAS IMPLANTED ON (B)(6) 2023 AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007606 ↗
• MalfunctionMay 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON WAS INSERTING A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.00/+1.0/166 (SPHERE/CYLINDER/AXIS) IN THE PATIENTS LEFT EYE (OS) AND THE LENS TORE/BROKE WHILE DISCHARGING. THERE WAS NO PATIENT CONTACT. 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 16864769 ↗
• InjuryApr 17, 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; -9.0/+1.0/94 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. THE PATIENT EXPERIENCED LOW VAULTING. ON 23-MAR-2023 THE LENS WAS EXPLANTED AND ON THIS SAME DATE REPLACED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16757610 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -9.00/1.0/071 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. IT WAS INDICATED THAT EVERYONE WAS NORMAL FOR THE 1ST FOUR DAYS AFTER SURGERY BUT ON THE 5TH DAY THE EYE WAS DILATED; WAS PRESCRIBED MEDICATION (PILOCARPINE); BUT PIGMENT DISPERSION STARTED AND RED EYE AND SERVER EYE PAIN. A DIFFERENT SURGEON HAD REPOSITIONED THE LENS BUT THIS DID NOT RESOLVE THE PROBLEM. A 3RD DOCTOR HAD PRESCRIBED ALPHAGAN P. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Pain; Red Eye(s)

  MAUDE report 16739723 ↗
• MalfunctionMar 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.00/+1.0/084 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPORTED AS LOW VAULTING AND REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554754 ↗
• InjuryFeb 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM_12.6; -9.0/1.0/069 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED LOW VAULTING. ON (B)(6) 2023 THE LENS WAS EXPLANTED; ON THIS SAME DATE IN A SEPARATE SURGERY A REPLACEMENT LENS OF A LONGER LENGTH LENS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413764 ↗

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-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.
• 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.