EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.5/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311311132), received between Nov 3, 2023 and Aug 4, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryAug 4, 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 and lens rotation. The lens was later exchanged for a longer length lens at a different axis and the problem was resolved. Cause of the event is unknown.

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

  MAUDE report 50136610 ↗
• InjuryApr 20, 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, ELEVATED IOP, PUPIL BLOCK, ANGLE CLOSURE AND SIGNIFICANT SHALLOWING OF AC. THE LENS WAS EXPLANTED AND PROBLEM WAS 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 UNKNOWN.

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

  MAUDE report 24931435 ↗
• InjuryDec 27, 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. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. 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 23903165 ↗
• InjuryDec 17, 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 PERSISTENT POSTOPERATIVE INFLAMMATION. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE CAUSE IS REPORTED AS UNKNOWN.

  Patient problems: Inflammation

  MAUDE report 23830761 ↗
• InjuryOct 31, 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 EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 23441722 ↗
• MalfunctionSep 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SAME LENGTH LENS BUT IMPLANTED VERTICALLY AS OPPOSED TO THE INITIAL HORIZONTAL IMPLANT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND NOTED THE DEVICE STILL FAILED TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294279 ↗
• MalfunctionJul 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED GLARE FROM OVERHEAD LIGHTS AT WORK. 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. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Visual Disturbances

  MAUDE report 19779755 ↗
• InjuryJun 21, 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.50/1.0/079 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED LENS DISLOCATION/SUBLUXATION, PIGMENT DISPERSION, UNREACTED (FIXED) PUPIL, RETINAL DETACHMENT AND LENS REPOSITIONING. ON (B)(6) 2023 THE LENS WAS EXPLANTED. ON THE SAME DAY SEPARATE SURGERY THE LENS WAS REPLACED WITH THE SAME MODEL, LONGER LENS. THE REPORTER INDICATED THE CAUSE OF THE EVENT IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 19580412 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON INTRAOPERATIVELY IMPLANTED AND REMOVED A 13.2MM VTICM5_13.2 -7.50/1.0/092 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS FROM THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. LENS WAS IMPLANTED UPSIDE DOWN. REPORTEDLY, "NEW LENS IMPLANTATION IS NOT SCHEDULED FOR THE MOMENT." CAUSE OF EVENT WAS NOT REPORTED.

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

  MAUDE report 19459601 ↗
• MalfunctionMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 -7.50/1.0/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS TORE BEFORE/DURING LOADING. A BACKUP LENS WAS IMPLANTED ON (B)(6) 2024. CAUSE OF EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373626 ↗
• InjuryNov 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF -7.50/1.00/064 (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 LONGER LENGTH LENS DUE TO LOW VAULT. THE EXCHANGE DID NOT RESOLVED THE PROBLEM. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062744 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.