Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542109031), received between Apr 10, 2019 and Aug 27, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS -10.0/+2.0/078 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE. REPORTEDLY, THE LENS WAS EXPLANTED DUE TO VAULT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378549 ↗
• InjuryFeb 16, 2021Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -10.00/+2.0/070 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS REPORTED AS HAVING LOW VAULTING, WITH LENS ROTATION AND PATIENT EXPERIENCED IRITIS. THE PLAN IS TO EXPLANT AND EXCHANGE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Iritis; UGH (Uveitis Glaucoma Hyphema) Syndrome

  MAUDE report 11334451 ↗
• MalfunctionMay 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 A HAPTIC OF A 13.2MM, TMICL13.2, -10.00/2.0/087 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMAR LENS TORE "WHILE REMOVING FROM VIAL OR WHILE LOADING, WITH NO PATIENT CONTACT AND NO PATIENT INJURY. BACK UP LENS WAS IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8611922 ↗
• InjuryApr 10, 2019Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -10.00/2.0/066 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. ELEVATED IOP (35MMHG) WITHOUT PUPIL BLOCK AND ANGEL CLOSURE AND LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED, THE LENS WAS REPOSITIONED ON (B)(6) 2019 AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8501145 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.