EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-14.5) (REF VICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840311302093), received between Apr 5, 2023 and May 19, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 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 OVER/UNDER CORRECTION. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. CAUSE 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: Blurred Vision

  MAUDE report 25224883 ↗
• InjuryMar 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 PIGMENT DISPERSION. PIGMENTS AND EXUDATES ATTACHED TO ICL SURFACE. MEDICATION ADMINISTERED. LENS REMAINS IMPLANTED. 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 EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 21679162 ↗
• InjuryFeb 7, 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 LOW VAULTING, WITH NO LENS ROTATION, AND CAPSULAR TEAR. THE LENS WAS EXCHANGED WITH A LONGER 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; Cataract

  MAUDE report 21339511 ↗
• InjuryJan 10, 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 AS A REPLACEMENT LENS. THE PATIENT CONTINUED TO EXPERIENCE MYDRIASIS, AND IT WAS NOTED "UBM DEMONSTRATES IRIS TOUCHING THE LENS". LENS REMAINS IMPLANTED.

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

  MAUDE report 21130120 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE IMPLANT OF AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE, MILD TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED THIRTY DAYS AFTER INITIAL IMPLANTATION. PATIENT COMPLAINED OF BLURRED VISION AND PHOTOPHOBIA. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDED OPEGAN VISCOELASTIC AND THE SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER. DIAGNOSTIC CULTURE WAS NOT PERFORMED. ONE WEEK AFTER SURGERY THE PATIENT WAS PRESCRIBED STANDARD STEROID AND TREATMENT INCLUDED: LEVOFLOXACIN HYDRATE, BETAMETHASONE BUTYRATE PROPIONATE, BROMFENAC SODIUM HYDRATE AND HYALURONIC ACID. AFTER THE ONSET OF POSTOPERATIVE INFLAMMATION, THE PATIENT WAS STARTED WITH BETAMETHASONE EYE DROPS TWO TIMES AND AFTER ONE MONTH, WAS REDUCED TO ONE TIME. THE LENS REMAINS IMPLANTED WITH THE ISSUE RESOLVED. PER POST-OP VISIT, PATIENT CONDITION WAS BCVA: 20/13; IOP: 17 MMHG. THE REPORTER DOES NOT PROVIDE A CAUSE FOR THE EVENT.

  Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20846318 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO A RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPELEAD OVD, THE MSI INJECTOR DELIVERY SYSTEM AND DISPOSABLE CANNULA WITH BSS FOR ITS REMOVAL FOR 30 SEC. TASS WAS DIAGNOSED AND DESCRIBED AS SEVERE INFLAMMATION PRESENTING WITH AC CELL+, CONJUNCTIVAL HYPEREMIA AND MILD FIBRIN OVER THE PUPIL RESULTING IN PATIENT EXPERIENCE OF BLURRED VISION. TREATMENT INCLUDED: TOPICAL, ORAL AND SUBCONJUNCTIVAL INJECTION OF STEROIDS. ON DAY 7 RECOVERY WAS NOTED. BY THE LAST REPORT DATED (B)(6) 2024, THE ISSUE WAS RESOLVED WITH BCVA 20/17 AND IOP 12.5MMHG. THE LENS REMAINS IMPLANTED. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20843789 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT A 12.6MM VICM0 -14.5D IMPLANTABLE COLLAMER LENS (ICL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN OVD AND THE MSI INJECTOR DELIVERY SYSTEM. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. ADDITIONAL DIAGNOSTICS WERE PERFORMED BUT CULTURES WERE NOT TAKEN. EYE DROPS AND ORAL MEDICATION WERE PRESCRIBED. AS OF (B)(6) 2024 ISSUES WERE REPORTED TO BE RESOLVED WITH PATIENT CONDITION: BCVA/UCVA:20/13; IOP:13.2MMHG; VAULT:431 ¿M;" PIGMENTATION HAS IMPROVED CONSIDERABLY. "THE LENS REMAINS IMPLANTED. IN THE REPORTER OPINION, THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20700571 ↗
• InjuryMay 20, 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 VICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.50 INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. REPORTEDLY "VISION IS NOT CLEAR". ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR THE SAME MODEL AND LENGTH. STATUS OF THE EYE: "GOOD". ADDITIONAL INFORMATION PROVIDED: "NEAR VISION IS NOT CLEAR, THE PATIENT REQUESTS A LENS REPLACEMENT". THE REPORTER INDICATED THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 19355485 ↗
• InjuryMay 6, 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 VICMO_12.6 IMPLANTABLE COLLAMER LENS, OF DIOPTER -14.5, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 LENS WAS EXCHANGED WITH A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249732 ↗
• InjuryMar 5, 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 VICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842884 ↗
• MalfunctionDec 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON 30-OCT-2023 A 12.6MM, VICMO12.6, -14.50 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY. ON (B)(6) 2023 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340572 ↗
• InjurySep 21, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LENS TWO SIZES LONGER IN LENGTH DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795197 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, VICMO12.6 IMPLANTABLE COLLAMER LENS OF -14.50 DIOPTER TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REMOVED, A REPLACEMENT LENS WAS IMPLANTED ON THIS SAME DATE BUT DIFFERENT SURGERY AND THE PROBLEM RESOLVED. NO PATIENT INJURY WAS REPORTER. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410714 ↗
• InjuryApr 24, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICMO12.6, -14.50 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT ON (B)(6) 2023. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16794629 ↗
• MalfunctionApr 5, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICMO12.6; -14.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS HAD BECAME STUCK IN THE CARTRIDGE/INJECTION SYSTEM AND ALSO TORE DURING INJECTION/DELIVERY INTO THE EYE. THE DAMAGE WAS NOTED AFTER THE LENS OPENED UP INSIDE THE EYE. REPOSITIONING WAS ALSO PERFORMED INTRAOPERATIVELY DURING THIS TIME BUT IT DID NOT RESOLVE THE PROBLEM. THE LENS WAS INTRAOPERATIVELY REMOVED AND REPLACED WITH A SAME LENGTH LENS AND THIS RESOLVED THE PROBLEM. IT WAS NOTED "NORMAL; NO ADVERSE EVENTS". THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND UNKNOWN AND NOTED "UNKNOWN; LOADED AS PER NORMAL; INJECTION FELT NORMAL; DAMAGE HAPTIC NOTED ONCE ICL UNFOLDED". THE DEVICE DID FAIL TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685687 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.