Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-14.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542109574), received between Jul 7, 2020 and Feb 7, 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.

• InjuryFeb 7, 2022Inadequacy 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; -14.00/1.0/026 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. IT WAS REPORTED THAT THE SIZE IS TOO LARGE CAUSING DANGEROUS VAULT AND INTERMITTENT ANGLE CLOSURE. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. 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 13476664 ↗
• InjuryFeb 7, 2022Inadequacy 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; -14.00/1.0/145 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 202. IT WAS REPORTED THAT THE SIZE IS TOO LARGE CAUSING DANGEROUS VAULT AND INTERMITTENT ANGLE CLOSURE. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. 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 13476644 ↗
• InjuryJan 18, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -14.00/+1.0/074 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO PATIENT EXPERIENCED A REFRACTIVE SURPRISE (VA WAS 20/400) AND BLURRED VISION. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH BUT DIFFERENT DIOPTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT IS DOING WELL.

  Patient problems: Blurred Vision

  MAUDE report 13286530 ↗
• MalfunctionJul 7, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON WAS ATTEMPTING TO INSERT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -14.00/+1.0/040 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS) AND NOTED THE LENS WAS TORN BEFORE IMPLANTING. THE BACKUP LENS WAS USED. 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 10242498 ↗

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