Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.0/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542109161), received between Apr 9, 2019 and Sep 8, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -11.0/1.5/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS LATER EXPLANTED DUE TO EXCESSIVE VAULT. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS):" HAPPY WITH VISION. SHALLOW AC, VERY HIGH VAULT AND NARROW ANGLES" WAS REPORTED. IT WAS ALSO REPORTED THAT THIS CASE IS PENDING ICL REPLACEMENT FOR SHORTER LENGTH. CAUSE OF EVENT WAS UNKNOWN. 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 12443370 ↗
• MalfunctionMay 13, 2021Optical Problem; Optical Problem

  THE REPORTER/PATIENT INDICATED THAT A 13.2MM, TMICL13.2, -11.00/1.5/053 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. REPORTEDLY, "GLARE, VISUAL QUALITY IS BAD AND NOT IMPROVING." LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Visual Disturbances

  MAUDE report 11820848 ↗
• MalfunctionOct 27, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -11.00/+1.5/104 (SPHERE/CYLINDER/AXIS), WITHIN THE SAME SURGERY DUE TO SIZING ISSUE (TOO LARGE). THERE WAS NO PATIENT INJURY. THE LENS WAS EXCHANGED FOR A SHORTER LENS ON (B)(6) 2020 AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10740471 ↗
• InjuryAug 26, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -11.0/+1.5/172 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE UPSIDE DOWN. THIS OCCURRED ON (B)(6) 2020. THE LENS WAS EXPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL ELEVATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 10457364 ↗
• MalfunctionAug 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -11.0/1.5/108 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS NOTED TO BE TORN IN THE INJECTOR. THERE WAS NO PATIENT CONTACT OF INJURY AND A BACKUP LENS WAS IMPLANTED. A STAAR INJECTOR SYSTEM WAS USED BUT MODEL AND LOT NUMBERS ARE UNKNOWN. THE REPORTER STATED " I THINK THE LENS TEAR WAS DUE TO THE FOAM TIP PLUNGER NOT SEATING TIGHTLY INTO THE INJECTOR".

  Patient problems: No Patient Involvement

  MAUDE report 8902740 ↗
• InjuryApr 9, 2019Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 LENS, -11.0/+1.5/114 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED A SAME SIZE, DIFFERENT MODEL LENS DUE TO LOW VAULT, LENS ROTATION, PIGMENT DISPERSION, REFRACTIVE CHANGE OVER TIME, GLARE/HALOS, BLURRED VISION, AND IRIS ATROPHY. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Disturbances

  MAUDE report 8497526 ↗

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