EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00840311300563), received between Apr 6, 2023 and Sep 22, 2026 — classified as 23 injuries, 8 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 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 over/under correction. The lens was later exchanged for a same size, different power lens and the problem was resolved.

  Patient problems: Blurred Vision

  MAUDE report 50849607 ↗
• InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50834785 ↗
• InjurySep 16, 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 lens rotation. The lens was repositioned and the lens was exchanged for the same length, different model lens and diopter and the problem was resolved. The cause of the event was reported as a patient-related factor. It was noted that laser surgery was performed for astigmatism.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791323 ↗
• InjuryAug 26, 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. Lens was exchanged for a different power lens and problem was resolved. Cause of the event was reported as patient related factor.

  Patient problems: Blurred Vision

  MAUDE report 50464684 ↗
• InjuryJul 27, 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. Reportedly, 'patient was dissatisfied with the residual astigmatism. Consequently the surgeon decided to change the model from ICL to TICL to correct the astigmatism'. In a separate surgery the lens was exchanged with a toric model 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 50048107 ↗
• InjuryJun 22, 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. LENS WAS EXCHANGE FOR SAME LENGTH BUT DIFFERENT POWER AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 25587981 ↗
• InjuryMar 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 BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR SAME SIZE TORIC MODEL LENS. THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS OTHER.

  Patient problems: Blurred Vision

  MAUDE report 24630446 ↗
• InjuryDec 24, 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 CORNEAL EDEMA AND IRIS ATROPHY. REPORTEDLY, "THREE MONTHS AFTER THE SURGERY, THE PATIENT'S IRIS BEGAN TO LOSE PIGMENTATION. THE DOCTOR REPORTS THAT THE PATIENT EXPERIENCED CORNEAL EDEMA POST-SURGERY, WHICH RESOLVED AFTER 3 WEEKS. NO INFLAMMATORY REACTION AND NO IRIS PIGMENT ON THE LENS." MEDICATION WAS ALSO PROVIDED. LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889642 ↗
• InjuryOct 30, 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 LENS OPACITY (NS). THE LENS WAS EXPLANTED AND A MULTI FOCAL LENS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Cataract

  MAUDE report 23430654 ↗
• InjuryAug 29, 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 REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A DIFFERENT POWER LENS AND THE PROBLEM 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. 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 22929526 ↗
• 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 A REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS OF A DIFFERENT MODEL AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT LISTED AS OTHER, "REFRACTIVE SURPRISE, LOW ACCOMMODATIVE AMPLITUDE DUE TO PATIENT AGE."

  Patient problems: Blurred Vision

  MAUDE report 22476487 ↗
• InjuryJul 1, 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 TOXCI ANTERIOR SEGMENT SYNDROME (TASS). NO DIAGNOSTIC CULTURES WERE PERFORMED. BILATERAL SEQUENTIAL SURGERY WAS PERFORMED. PATIENT WORE CONTACT LENS PRIOR TO ICL SURGERY AND USED OPHTHALMIC DROPS - PURIFIED SODIUM HYALURONATE AND MOXIFLOXACIN. PATIENT WAS COMPLIANT. LENS EXPLANTED AND REPLACED WITH DIFFERENT DIOPTER LENS. PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 22372665 ↗
• InjuryMay 23, 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 (ICL) WAS IMPLANTED AS AN EXCHANGE LENS. THE ISSUE WAS REPORTED TO HAVE BEEN RESOLVED; HOWEVER, IT WAS REPORTED THAT " LASER IS PENDING TO CORRECT ASTIGMATISM. THE ICL WAS CHANGED TO A SPHERICAL ONE TO AVOID ROTATION, AND ALTHOUGH WE'RE STILL WAITING FOR LASER TOUCH-UP, THE PATIENT IS DOING FINE".

  Patient problems: Blurred Vision

  MAUDE report 22080942 ↗
• InjuryFeb 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS OF SAME LENGTH DIFFERENT POWER. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 21445521 ↗
• InjuryDec 6, 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 HYPERVAULT. THE LENS WAS REMOVED AND REPLACED WITH A SMALLER/SHORTER LENGTH LENS. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870434 ↗
• InjuryNov 22, 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 EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761622 ↗
• InjuryAug 26, 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 LENS WAS EXCHANGED WITH A SAME LENGTH LENGTH TORIC LENS. A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063959 ↗
• MalfunctionJul 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ISSUES. THE LENS WAS TORN/BROKEN DURING INJECTION/DELIVERY INTO THE EYE AND THE LENS WAS REMOVED. THE LENS WAS REPLACED AT A LATER DATE FOR ANOTHER SAME MODEL/LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733774 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS EXPLANTED ON (B)(6) 2024 DUE TO LOW VAULT WITHOUT ROTATION. IN A SEPERATE SURGERY ON THE SAME DAY IT WAS REPLACED WITH A SAME MODEL BUT LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS UNKNOWN. CLAIM #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595445 ↗
• MalfunctionJun 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6; -8.00 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS NO PATIENT CONTACT. A BACK UP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563704 ↗
• MalfunctionJun 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6; -8.00 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS NO PATIENT CONTACT. A BACK UP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THIS OCCURRED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19555093 ↗
• MalfunctionJun 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6; -8.00 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING LOADING, WHILE THE LENS WAS IN THE CARTRIDGE. THIS OCCURRED ON (B)(6) 2024. 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 19488297 ↗
• MalfunctionApr 27, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.00 INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. REPORTEDLY THE LENS GOT STUCK IN THE CARTRIDGE/INJECTION SYSTEM. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY WITH A BACKUP LENS. ADDITIONAL INFORMATION PROVIDED: "DURING LENS INSERTION WITH THE INJECTOR, THE LENS ROTATED ABOUT 10 DEGREES TO 15 DEGREES WITHIN THE EYE. SINCE THE FRONT AND BACK OF THE LENS SEEMED TO FLIP OVER WITHIN THE ANTERIOR CHAMBER, INSERTION WAS ABORTED AND THE LENS WAS REMOVED". THE REPORTER INDICATED THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19198938 ↗
• MalfunctionApr 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.00 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT EXPERIENCED AN EXCESSIVE VAULT. THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY WITH THE SAME MODEL, SHORTER LENGTH AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19073108 ↗
• MalfunctionMar 26, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A PARTICLE ON A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF -8.00 DIOPTER WAS REPORTED. THERE WAS NO PATIENT CONTACT. ON 23-FEB-2024 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983282 ↗

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