Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542109505), received between Nov 5, 2019 and Aug 26, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• MalfunctionAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -13.50/1.00/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE PATIENT EXPERIENCED IRIS TRANSILLUMINATION, LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS REPORTED TO BE THE DEVICE. 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 15299561 ↗
• InjuryApr 6, 2022Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A TICL TORIC IMPLANTABLE COLLAMER LENS. WHEN INSERTING THE LENS, THE SURGEON THOUGHT THE LENS MAY HAVE BEEN INSERTING UPSIDE DOWN, BUT WHEN THE LENS UNFOLDED IN THE EYE, THE LENS WAS PROPERLY UNDER THE IRIS IN THE CORRECT ORIENTATION. AT ONE DAY POST-OP, THE EYE HAD A VERY SHALLOW ANTERIOR CHAMBER, INAPPRECIABLE VAULT AND UNRECORDABLE INTRAOCULAR PRESSURE (IOP). THE SURGEON REALIZED THERE WAS A SMALL WOUND LEAK AND HE REPAIRED IT WITH ONE SUTURE. THE ANTERIOR CHAMBER DEEPENED, THERE WAS APPRECIABLE VAULT AND IOP WAS LOW BUT RECORDABLE. 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

  MAUDE report 14030182 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -13.50/+1.0/074 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS). THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO A HIGH PRESSURE SPIKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 11405310 ↗
• InjuryNov 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -13.5/1.0/135 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, PUPIL BLOCK WITH ELEVATED IOP (INTRAOCULAR PRESSURE) AND BLURRED VISION. A REPLACEMENT LENS OF SHORTER LENGTH WAS LATER IMPLANTED AND THE PROBLEM RESOLVED.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; No Code Available

  MAUDE report 9282596 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• 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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.