EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.0/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311308163), received between Mar 23, 2023 and Sep 18, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  The reporter indicated that following an implantable collamer lens (ICL) implantation procedure, the patient experienced elevated IOP, pain, worse vision and shallowing of anterior chamber. Medication was administered. The lens remains implanted. Final patient status is unknown. Cause of the event is unknown. Additional information was requested. No further information is available at this time. This file will be re-opened if additional information is provided.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 50821133 ↗
• InjuryAug 8, 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 WITHOUT REPOSITIONING AND BLURRED VISION. THE LENS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 22750504 ↗
• InjuryApr 17, 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 LENS ROTATION NOT ASSOCIATED WITH LOW VAULTING. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT AXIS LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859334 ↗
• MalfunctionJul 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS IMPLANTED UPSIDE DOWN INTO THE EYE. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY. PATIENT CONTACT(LENS TOUCHED THE EYE) AND NO PATIENT INJURY. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749434 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -13.0/1.5/121 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2024. THE SURGEON REPORTS THERE IS REFRACTIVE SURPRISE. THE PATIENT IS ON MONOPROST FOR IOP. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THE PROBLEM IS NOT RESOLVED.

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 19076765 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -13.0/1.5/164 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. THE SURGEON REPORTS THERE IS TASS AND ADDITIONALLY REPORTED - FIBRIN, STRONG FLARES, ADHESIVE AROUND EYE, MEDICATION USED. THE SURGEON REPORTS THERE WILL BE NOT ADDITIONAL INTERVENTION AS THE SYMPTOMS HAVE RESOLVED. LENS REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18547783 ↗
• MalfunctionSep 14, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A:13.00/1.5/082 (SPHERE/CYLINDER/AXIS) LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT OR INJURY. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750468 ↗
• InjuryJul 3, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -13.00/1.5/103 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS REMOVED DUE TO ELEVATED IOP WITHOUT PUPIL BLOCK AND ANGLE CLOSURE. THE PROBLEM WAS RESOLVED. DEVICE WAS MENTIONED AS THE CAUSE OF THE EVENT. REPORTEDLY, "ANTERIOR CATARACT. FIXED BLOWN PUPIL WITH SYNECHAIE."

  Patient problems: Intraocular Pressure Increased

  MAUDE report 17253137 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -13.0/1.5/003 (SPHERE/CYLIDNER/AXIS) WAS IMPLANTED AS A REPLACEMENT INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 DUE TO REFRACTIVE SUPRISE. REPORTEDLY, "POSTOPERATIVE DAY 1 IOP AND I/A IS PERFORMED. CURRENTLY, DOCTOR IS TAKING A WAIT-AND-SEE APPROACH." THE CAUSE OF THE EVENT WAS UNKNOWN. THE PROBLEM WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16600700 ↗

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-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-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.