EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-15.0) (REF VICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311302109), received between Nov 17, 2022 and Feb 7, 2025 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 21339512 ↗
• InjuryApr 8, 2024Adverse 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 -15.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)6) 2024. SAME DAY BILATERAL ICL IMPLANTATION WAS PERFORMED. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC AND MSI INJECTOR SYSTEM. ON DAY 2, THE PATIENT EXPERIENCED SIGNIFICANT VISION LOSS AND WENT TO HOSPITAL WHERE ANTERIOR CHAMBER EMPYEMA (HYPOPYON) WITH A FIBRIN MEMBRANE WAS NOTED IN THE PUPILLARY AREA. NO CULTURES WERE TAKEN. TREATMENT WITH RINDERON SUBCONJUNCTIVAL INJECTION AND SUNBETA HOURLY WERE GIVEN. AFTER ANTERIOR CHAMBER IRRIGATION THE VISION IMPROVED TO "RV 1.2 (~20/16), LV 1.0 (20/20)." REPORTEDLY, BILATERAL TASS WAS OBSERVED AS WELL. IN THE REPORTER'S OPINION, THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED AND CAUSE OF THE EVENT IS UNKNOWN. ON DAY 4, THE ISSUE WAS REPORTED AS UNRESOLVED. THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19068387 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VICMO -15.00D IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OS) ON (B)(6) 2024. SAME DAY BILATERAL ICL IMPLANTATION WAS PERFORMED. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC AND THE MSI INJECTOR SYSTEM. ON DAY 2, THE PATIENT EXPERIENCED SIGNIFICANT VISION LOSS AND WENT TO HOSPITAL WHERE ANTERIOR CHAMBER EMPYEMA (HYPOPYON) WITH A FIBRIN MEMBRANE WAS NOTED IN THE PUPILLARY AREA. NO CULTURES WERE TAKEN. TREATMENT WITH RINDERON SUBCONJUNCTIVAL INJECTION AND SUNBETA HOURLY WERE GIVEN. AFTER ANTERIOR CHAMBER IRRIGATION THE VISION IMPROVED TO "RV 1.2 (~20/16), LV 1.0 (20/20)". REPORTEDLY, BILATERAL TASS WAS OBSERVED AS WELL. IN THE REPORTER'S OPINION, THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED AND CAUSE OF THE EVENT IS UNKNOWN. ON DAY 4, THE ISSUE WAS REPORTED AS UNRESOLVED. THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19068386 ↗
• InjuryFeb 23, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. IN A SUBSEQUENT SURGERY LATER THAT DAY, THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT AND ELEVATED IOP.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16433266 ↗
• MalfunctionNov 17, 2022Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM, VICMO12.6, -15.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED UPSIDE DOWN INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022.THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY AND THE PROBLEM RESOLVED. IT WAS REPORTED THAT THE LENS WAS DAMAGED UPON REMOVAL. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15819845 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.