EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-5.5) (REF VICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311300181), received between Jun 1, 2023 and Aug 7, 2026 — classified as 7 injuries, 2 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced monocular diplopia. Reportedly, "the patient complaint of monocular diplopia in the right eye (OD). The patient was followed up over time, but no abnormal findings were detected on examination." The lens was later exchanged for a same size lens and the problem was resolved.

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

  MAUDE report 50184532 ↗
• InjuryJun 25, 2026Adverse 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 INCREASED ASTIGMATISM (REFRACTIVE OVER/UNDER CORRECTION). THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER LENS. 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 25630528 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED MILD TOXIC ANTERIOR SEGMENT SYNDROME. TREATMENT WAS PERFORMED AND PROBLEM RESOLVED. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS OTHER: TASS. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 25379575 ↗
• InjuryMar 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 DIOPTER. 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 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 21678626 ↗
• 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 THE MSI-PF INJECTOR, SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER, OVD (B)(6) AND COAXIAL I/A HANDPIECE FOR ITS REMOVAL FOR 60 SEC. TASS WAS DIAGNOSED ON DAY 1. INFLAMMATION WAS REPORTED AS MODERATE PRESENTING WITH AC CELL+++, CILIARY HYPEREMIA AND MILD FIBRIN OVER THE PUPIL RESULTING IN PATIENT EXPERIENCE OF BLURRED VISION. TREATMENT INCLUDED: AC LAVAGE, TOPICAL, ORAL AND SUBCONJUNCTIVAL INJECTION OF STEROIDS. THE ISSUE WAS RESOLVED ON DAY 2 AND THE LENS REMAINS IMPLANTED. PER INFORMATION ON (B)(6)2024, OCULAR STATUS WAS REPORTED AS UCVA 20/13 AND IOP 11MMHG. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20843322 ↗
• InjurySep 27, 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. THE 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. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 20327784 ↗
• MalfunctionJul 25, 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 AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED LOW VAULTING. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834493 ↗
• MalfunctionMar 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS, -05.50 DIOPTER, WAS STUCK IN CARTRIDGE OR INJECTION SYSTEM. THERE WAS PATIENT CONTACT BUT NO INJURY. THE SURGEON NOTED WHEN THE LENS WAS REMOVED OUT OF THE VIAL, WHAT LOOKED LIKE A SCRATCH ON THE LENS. THE SURGEON DECIDED TO USE THE LENS AND IT JAMMED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914568 ↗
• InjuryJun 1, 2023Adverse 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 VICMO12.1, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. TOXIC ANTERIOR SEGMENT SYNDROME(TASS) AND BLURRED VISION WAS OBSERVED. ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS AND ADDITION OF ORAL STEROIDS AND OINTMENTS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WASREPORTED AS UNKNOWN.

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

  MAUDE report 17039570 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.