Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-8.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542108836), received between Apr 2, 2019 and Sep 4, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, - 8.50/+2.5/087 (SPHERE/CYLINDER/AXIS), TORE DURING THE LOADING PROCESS, WHILE BEING INSERTED INTO THE CARTRIDGE. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8962472 ↗
• MalfunctionApr 3, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -8.50/+2.5/090 (SPHERE/CYLINDER/AXIS), WAS DAMAGED DURING LOADING AND THERE WAS NO PATIENT CONTACT OR INJURY. THE BACKUP LENS WAS USED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO THE LENS. THE REPORTER DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8480532 ↗
• InjuryApr 2, 2019Inadequacy 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 IMPLANTABLE COLLAMER LENS, -8.5/+2.5/103 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT, ELEVATED IOP, PUPIL BLOCK, AND ANGLE CLOSURE. IN ADDITION, THE SURGEON PERFORMED ENLARGEMENT OF THE PI. NO ADDITIONAL INFORMATION CURRENTLY AVAILABLE REGARDING PATIENT'S CONDITION AFTER LENS EXCHANGE.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8475395 ↗

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