Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.0/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542106856), received between Jul 30, 2019 and Oct 6, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2020Device Dislodged or Dislocated; Optical Problem; Device Dislodged or Dislocated; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -10.00/+1.5/093 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE PATIENT REPORTED MILD GLARE AND HALOS AT NIGHT. THE LENS REMAINS IMPLANTED. THIS IS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2020-02067. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 10634467 ↗
• InjuryAug 26, 2020Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -10.00/1.5/111 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. PUPIL BLOCK WITH ELEVATED IOP (37MMHG) OBSERVED ON (B)(6) 2020. ADDITIONAL TREATMENT OF ENLARGEMENT OF PI AND A YAG WAS NECESSARY. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS NON PATENT PI. REPORTEDLY, PATIENT CONDITION "IMPROVED - NO COMPLAINTS."

  Patient problems: Blurred Vision; No Code Available; Pain

  MAUDE report 10454797 ↗
• MalfunctionFeb 4, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AND REMOVED A 12.6MM TMICL12.6, -10.00/1.5/080 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). THE LENS TORE DURING INJECTION. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. A BACK-UP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664306 ↗
• MalfunctionJul 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -10.0/1.5/070 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE WHILE LOADING. THERE WAS NO PATIENT CONTACT. ANOTHER LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Patient Involvement

  MAUDE report 8841796 ↗

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-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-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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.