EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.5/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542116800), received between Sep 8, 2022 and Aug 27, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Misfocusing” (3 reports).

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.

• InjuryAug 27, 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 FACULTY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS SIZE LOOKS TOO BIG INSIDE THE EYE. PLANNED LENS REMOVAL AND REPLACEMENT. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE 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. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075932 ↗
• MalfunctionJan 29, 2024Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -11.5/2.0/095 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). REFRACTIVE SURPRISE/REFRACTIVE CHANGE OVERTIME WAS OBSERVED, THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 18596264 ↗
• InjuryDec 16, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -11.50/+2.0/072 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REMOVED DUE TO HIGH VAULTING. THE LENS WAS SUCCESSFULLY REPLACED WITH A SHORTER LENS WITH NO PATIENT HARM. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000210 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AN EVO ICL IMPLANTABLE COLLAMER LENS. THE SURGEON REPORTED LATE POSTOPERATIVE PUPILLARY BLOCK WITH FIBRIN OCCLUDING THE PUPIL. THE SURGEON PERFORMED A PI, WHICH RESOLVED THE HIGH IOP. CULTURE OF THE OCCLUSION WAS NEGATIVE AND THE PATIENT DID WELL. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Pupillary Block; Retinal Detachment

  MAUDE report 15990641 ↗
• InjuryNov 22, 2022Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -11.50/+2.0/088 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS HAD EXCESSIVE VAULTING AND THE PATIENT EXPERIENCED GLARE/HALOES AND BLURRED VISION. THE LENS REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15847565 ↗
• InjurySep 15, 2022Misfocusing; Patient Device Interaction Problem; Misfocusing; Patient Device Interaction Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.50/2.0/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO EYE PAIN; ANGLE CLOSURE WITH ELEVATED IOP AND BLURRED VISION. "PAIN IN RIGHT SIDE AFTER IMPLANTATION. PUSHING FORWARD ON IRIS. GLAUCOMA SUSPECT POSSIBLE." CAUSE REPORTED AS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Glaucoma; Intraocular Pressure Increased

  MAUDE report 15434301 ↗
• InjurySep 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 WITH A, -11.50/2.0/071 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE. IT IS REPORTED, "LENS TO BIG THEY WILL REMOVE AND IMPLANT A SMALLER SIZE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15386460 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.