Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-6.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542106382), received between Aug 12, 2020 and Oct 1, 2021 — classified as 3 injuries, 2 malfunctions.

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

• MalfunctionOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -6.5/2.5/90, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021 AS A REPLACEMENT LENS TO CORRECT EXCESSIVE VAULT AND ANGLE CLOSURE WITH IOP. FOR STATUS OF THE EYE (SIGNS/ SYMPTOMS): THE REPORTER STATED "2+ CELL, FORMED AC, LENS EDGE VISIBLE SUP AND INF. ANGLE NARROW AT NASAL & TEMP. OPEN BUT SHALLOW, DILATED IRIS." 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 12559075 ↗
• InjurySep 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM,TMICL12.6, -6.50/2.5/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENTS LEFT EYE (OS) AND REPLACED WITH A SHORTER LENGTH LENS DUE TO SIZING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530671 ↗
• InjurySep 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM,TMICL12.6, -6.50/2.5/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENTS RIGHT EYE (OD) AND REPLACED WITH A SHORTER LENGTH LENS DUE TO SIZING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530669 ↗
• MalfunctionMar 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON WAS INSERTING A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -06.50/+2.5/091 (SPHERE/CYLINDER/AXIS), AND THE SURGEON NOTED A CRINKLE IN THE LENS AND DECIDED NOT TO IMPLANT THE LENS. THERE WAS PATIENT CONTACT BUT NO INJURY, NO INCISION ENLARGEMENT OR SUTURES. THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585657 ↗
• InjuryAug 12, 2020Off-Label Use; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Off-Label Use; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -06.50/+2.5/089 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO LOW VAULTING AND LENS ROTATION THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO SMALL DIAMETER ICL CAUSED LOW VAULTING AND TORIC ICL ROTATION.

  Patient problems: No Code Available

  MAUDE report 10398712 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.