EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-5.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311311088), received between Aug 15, 2023 and Sep 29, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Misfocusing” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50935591 ↗
• InjuryFeb 23, 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, SIGNIFICATION REDUCTION OF IRIDOCORNEAL ANGLES, AND SIGNIFICANT SHALLOWING OF THE AC. THE LENS WAS LATER EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS 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 24423777 ↗
• InjuryFeb 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 EXCHANGED FOR THE SAME SIZE BUT DIFFERENT POWER. THE REPLACEMENT LENS RESOLVED THE PROBLEM.

  Patient problems: Blurred Vision

  MAUDE report 24393704 ↗
• InjuryNov 13, 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 EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, AND SHALLOWING OF THE AC. 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 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 23548310 ↗
• InjuryFeb 6, 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 EXPERIENCED REFRACTIVE SURPRISE. REPORTEDLY "EXCHANGE DUE TO SWITCHED IMPLANTED LENSES (OD/OS)". IN A SEPARATE SURGERY THE LENS WAS EXCHANGED FOR THE SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER AND THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "EXCHANGE DUE TO CALCULATION ERROR (OD<=>OS)". THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 4 OF 4 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 21326943 ↗
• 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. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE: ACCUJECT UNIFIT INJECTOR, SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER, OVD (OPEGAN, OPEGAN HI) AND COAXIAL I/A HANDPIECE FOR ITS REMOVAL FOR 60 SEC. TASS WAS DIAGNOSED ON DAY OF THE SURGERY. THE REPORTER STATES ONSET OF INFLAMMATION CAUSED PUPIL BLOCK WITH ELEVATED IOP OF 67MMHG. OCULAR FINDINGS INCLUDE SEVERE FIBRIN, CELL+++ AND MODERATE HYPEREMIA. THE PATIENT PRESENTED WITH OCULAR PAIN, PHOTOPHOBIA AND BLURRED VISION. TREATMENT INCLUDED: AC LAVAGE, TOPICAL, ORAL AND SUBCONJUNCTIVAL INJECTION OF STEROIDS. PER THE LAST REPORT DATED ON (B)(6) 2024, THE ISSUE RESOLVED AND BCVA 20/13 (BETTER THAN PRE-OP) AND IOP 13MMHG WERE NOTED. THE LENS REMAINS IMPLANTED. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.

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

  MAUDE report 20849984 ↗
• InjuryMay 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -5.00/+1.0/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2024. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244973 ↗
• InjuryApr 11, 2024Adverse 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 A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF A -5.0/1.0/081 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE LEFT EYE (OS) OF A PATIENT WITH PRE-EXISTING PROGRESSIVE MYOPIA ON (B)(6) 2024. EXCESSIVE VAULT IS OBSERVED. CAUSE OF THE EVENT IS UNKNOWN WITH THE DEVICE NOT FAILING AS INTENDED. THE LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094083 ↗
• MalfunctionApr 5, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -5.0/1.0/179 (SPHERE/CYLINDER/AXIS), WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2024. IT WAS REPORTED THAT THE VIAL WAS DIRTY. THERE WAS NO IMPACT WITH THE PATIENT REPORTED WITH THE IMPLANTED LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054774 ↗
• InjuryNov 6, 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 A 13.2MM, VTICM5_13.2, -5.50/1.0/078 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. OVAL SHAPE PUPIL AT TEMPORAL WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075206 ↗
• InjuryAug 15, 2023Misfocusing; Misfocusing

  IT WAS REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) AND REFRACTIVE SURPRISE WAS OBSERVED. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 17552477 ↗

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-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.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.