Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-8.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542108737), received between Oct 6, 2020 and Feb 16, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2022Adverse 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; -8.00/+1.00/072 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THERE WAS REPORT OF PUPIL BLOCK AND ELEVATED INTRAOCULAR PRESSURE; ON (B)(6) 2022 IT WAS ALSO NOTED PATIENT EXPERIENCED MID DILATED PUPIL; UNCORRECTED VISUAL ACUITY; CORNEAL EDEMA AND A YAG PI SURGERY WAS PERFORMED WHICH RELIEVED THE PRESSURE AND WHEN THE PATIENT RETURNED (B)(6) 2022 THEY HAD IMPROVED VISUAL ACUITY/REDUCED INTRAOCULAR PRESSURE AND MID-DILATED PUPIL. THE PROBLEM WAS MARKED AS RESOLVED BUT NOTED PATIENT IS SCHEDULED TO COME IN FOR A 1 MONTH FOLLOW UP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Intraocular Pressure Increased; Pupillary Block

  MAUDE report 13546404 ↗
• MalfunctionDec 23, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 13.2MM TMICL13.2; -8.00/1.00/092 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS; THE LENS HAD TORE LOADING INTO THE CARTRIDGE. THIS OCCURRED ON (B)(6) 2021. A BACK UP LENS OF THE SAME MODEL/LENGTH AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS NOTED AS "OTHER" AND CLARIFIED THERE WAS NO PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13082028 ↗
• MalfunctionDec 21, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A LENS WAS RECEIVED DAMAGED IN THE PACKAGING AND WAS DISPOSED OF. IT WAS ALSO LATER REPORTED THAT "WHEN DR. NUNNERY TRIED TO INSERT THE ICL THE TORIC ETCHING MARKER WAS SO FAINT THAT HE COULD NOT VISUALIZE IN EYE. WE COULD NOT USE THIS ICL FOR SURGERY". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056802 ↗
• MalfunctionOct 6, 2020Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -8.00/1.0/109 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. RESIDUAL REFTRACTIVE ERROR WAS OBSERVED AND ROTATION. LENS REMAINS IMPLANTED. PER THE REPORTER ON (B)(6) 2020, "IT DOES NOT SEEM LIKE THE LENS ROTATED FAR FROM PLANNED ORIENTATION, AND FURTHER ROTATION IS NOT ADVISED." PATIENT WILL BE UNDER OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 10635480 ↗
• MalfunctionOct 6, 2020Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -8.00/1.0/071 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. RESIDUAL REFTRACTIVE ERROR WAS OBSERVED AND ROTATION. LENS REMAINS IMPLANTED. PER THE REPORTER ON (B)(6) 2020, "IT DOES NOT SEEM LIKE THE LENS ROTATED FAR FROM PLANNED ORIENTATION, AND FURTHER ROTATION IS NOT ADVISED." PATIENT WILL BE UNDER OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 10635478 ↗

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