EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-4.5) (REF VICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311300167), received between Sep 14, 2023 and Sep 24, 2026 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50888190 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT REQUIRED ADDITIONAL CORRECTION FOR RESIDUAL ASTIGMATISM. REPORTEDLY, "PATIENT REQUIRED LASIK RATHER THAN REPLACEMENT. THE LENS WAS REMOVED, AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS A PATIENT-RELATED FACTOR. 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 25395133 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT REQUIRED ADDITIONAL CORRECTION FOR RESIDUAL ASTIGMATISM. REPORTEDLY, "PATIENT REQUIRED LASIK RATHER THAN REPLACEMENT. THE LENS WAS REMOVED, AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS A PATIENT-RELATED FACTOR. 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 25395132 ↗
• InjuryJun 7, 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 INFLAMMATION AND ELEVATED IOP. REPORTEDLY, "PERSISTENCE AC REACTION." MEDICATION AS PROVIDED.

  Patient problems: Inflammation; Intraocular Pressure Increased

  MAUDE report 22163341 ↗
• 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: 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 1. OCULAR FINDINGS INCLUDE MILD EMPYEMA (SLIGHTLY RECOGNIZED), CELL++, AND CONJUNCTIVAL HYPEREMIA. THE PATIENT EXPERIENCED PAIN AND BLURRED VISION. MODERATE DEPOSITS WERE NOTED ON THE POSTERIOR OF ICL. TOPICAL AND ORAL STEROIDS WERE PRESCRIBED. BY DAY 2 RECOVERY WAS NOTED. 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: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20849548 ↗
• InjuryJul 16, 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SAME MODEL AND LENGTH LENS BUT DIFFERENT DIOPTER. THE REPLACEMENT LENS RESOLVED THE PROBLEM. THE CAUSE IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 19757312 ↗
• MalfunctionSep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VICM512.1 IMPLANTABLE COLLAMER LENS OF A -4.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO PATIENT DISSATISFACTION AND PAIN. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17751506 ↗

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