Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542109086), received between Oct 11, 2019 and Oct 20, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -10.50/+1.0/010 (SPHERE/CYLINDER/AXIS), TORE DURING LOADING, AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669507 ↗
• 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, -10.5/1.0/090 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) 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 12443368 ↗
• MalfunctionSep 7, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON WAS ATTEMPTING TO LOAD A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -10.50/+1.0/087 (SPHERE/CYLINDER/AXIS), AND THE LENS WOULD NOT LOAD INTO THE CARTRIDGE AND TORE. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE CAUSE OF THE EVENT WAS UNKNOWN. THE LENS WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437075 ↗
• MalfunctionSep 7, 2021Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -10.50/+1.0/132 (SPHERE/CYLINDER/AXIS), IS BEING RETURNED TO THE MANUFACTURER AND THE REASON IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437008 ↗
• MalfunctionOct 11, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -10.50/1.0/129 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE WHILE LOADING. REPORTER STATED " UNSURE IF PATIENT CONTACT". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9181367 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.