EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-15.0/1.5) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311327089), received between Apr 18, 2023 and Aug 28, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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.

• InjuryAug 28, 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 LOW VAULT WITH ROTATION. THE LENS WAS EXPLANTED AND REPLACED WITH A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919455 ↗
• InjuryJun 20, 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 AND A SHALLOW AC. REPORTEDLY, "THE LENSES ARE TOO LONG CAUSING SHALLOW AC". IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A SHORTER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER. CAUSE DETAILS PROVIDED: "LENS SIZING WAS INCORRECT DUE TO PATIENT ANATOMY WHICH COULD NOT BE PREDICTED PRIOR TO SURGERY". 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 22301311 ↗
• MalfunctionOct 31, 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 AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

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

  MAUDE report 20582479 ↗
• MalfunctionNov 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -15.00/1.5/091 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE EYE ON (B)(6) 2023. THE LENS TORE/BROKE DURING LOADING WHILE INJECTING INTO THE EYE. THE LENS WAS IMPLANTED AND REMOVED INTRA-OPERATIVELY ON (B)(6) 2023. A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18179726 ↗
• InjuryApr 18, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF -15.00/1.5/075 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. FIXED DILATED PUPIL; UNREACTIVE TO LIGHT WAS OBSERVED. THE REPORTER STATES "FROM DAY 1. PILOCARPINE USED WEEK 1 MINIMAL CONSTRICTION NOTED ON FFUP. PLANNING TO DO INTRACAMERAL DILATION. PRED AND OFTAQUIX WAS USED POST OP" . FOR PATIENTS CURRENT CONDITION THE REPORTER STATED THAT IOP WAS AT 11-13 AT ALL FFUPS; POST OP REFRACTION IS OS PLANO-0.75 X. LENS REMAINS IMPLANTED AND PUPIL IS STILL DILATED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 16766249 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.