Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542109154), received between May 28, 2019 and Aug 22, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT CATARACTS WAS OBSERVED IN PATIENT. LENS WAS IMPLANTED IN 2021. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Cataract

  MAUDE report 17595282 ↗
• InjuryApr 14, 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

  VAULT WAS REPORTER IN THE RIGHT EYE (OD) OF A PATIENT WITH AN IMPLANTABLE COLLAMER LENS. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions; Pupillary Block

  MAUDE report 14116256 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -11.00/1.0/129 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE PATIENT EXPERIENCED ANTERIOR SUBCAPSULAR CATARACT GRADE 1 (ASC). LENS REMAINS IMPLANTED.

  Patient problems: Cataract

  MAUDE report 12957841 ↗
• InjuryJul 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -11.00/+1.0/118 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULTING WITH ELEVATED INTRAOCULAR PRESSURE (IOP). THE SURGEON DID SOME ADDITIONAL LASER SURGERY TO THE IRIDOTOMY (ENLARGED) AND THAT RESOLVED THE ISSUE. THE PATIENT IS FINE AND THERE WAS NO NEED TO EXPLANT THE LENS, THE LENS REMAINED IMPLANTED. THE PROBLEM WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 12150435 ↗
• InjuryNov 18, 2019Inadequacy 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, -11.00/1.0/085 (SPHERE/CYLINDER/AXIS) , IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS REMOVED AND REPLACED ON (B)(6) 2019 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ELEVATED IOP (23 MMHG) .THIS RESOLVED THE PROBLEM. AN ENLARGEMTNE OF PI AND YAG WAS PERFORME. PER THE REPORTER, CAUSE OF THE EVENT IS REPORTED AS "STEEP VAULT.".

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9335805 ↗
• InjurySep 14, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, - 11.00/+1.0/086 (SPHERE/CYLINDER/AXIS), IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO PATIENT RELATED FACTOR.

  Patient problems: No Code Available

  MAUDE report 9056501 ↗
• InjuryMay 28, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13. 2 IMPLANTABLE COLLAMER LENS, - 11.00/+1.0/112 (SPHERE/CYLINDER/AXIS), IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. THE SURGEON IS PLANNING TO EXPLANT AND EXCHANGE THE LENS FOR A SMALLER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8648029 ↗

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-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.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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.