Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-5.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542108416), received between May 15, 2019 and Dec 3, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Misfocusing” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2020Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -5.50/2.5/161 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS DUE TO REFRACTIVE SURPRISE, GLARE/HALOES, AND BLURRED VISION. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS USER ERROR (USER TRANSPOSE ERROR, PLUS TO MINUS CYLINDER RESULTED IN THE INCORRECT DATA ENTRY.). REPORTEDLY, PATIENT SATISFIED WITH VISION.

  Patient problems: Blurred Vision

  MAUDE report 10937922 ↗
• InjuryOct 28, 2019Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 LENS, -5.5/+2.5/063 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXPLANTED DUE TO BLURRED VISION, DOUBLE-VISION, AND NEAR VERTICAL ROTATION OF LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 9246803 ↗
• InjuryMay 15, 2019Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -5.50/2.5/160 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. LOSS OF BCVA, LENS OPACITY (ASC), SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL COUNT OR SIGNIFICANT ENDOTHELIAL CELL LOSS, AND BLURRED VISION WAS OBSERVED. THE LENS WAS REMOVED ON (B)(6) 2019. PHACOEMULSIFICATION (CATARACT SURGERY) & IOL IMPLANTATION WAS PERFORMED. AS OF (B)(6) 2019 PATIENT'S "VISION IS GREAT." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Cataract; No Code Available

  MAUDE report 8611928 ↗

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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.