Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.7 (-6.0/4.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542110686), received between Apr 12, 2019 and Apr 12, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM TMICL13.7 IMPLANTABLE COLLAMER LENS, - 6.0/+4.0/096 (SPHERE/CYLINDER/AXIS), IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO PUPIL BLOCK, WITH ELEVATED INTRAOCULAR PRESSURE (IOP), ANGLE CLOSURE AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. PRIOR TO EXPLANT, GAVE THE PATIENT DIAMOX, TOPICAL OCULAR ANTIHYPERTENSIVE MEDICATIONS, THEN IV MANNITOL ATTEMPTING TO LOWER IOP, THEN ATTEMPTED TAPPED ANTERIOR CHAMBER AT SLIT LAMP ATTEMPTING TO LOWER IOP. THESE MEASURES WERE UNSUCCESSFUL AND IOP CONTINUED TO RISE. GONIOSCOPY DEMONSTRATED ANGLE CLOSURE, AND THE DECISION WAS MADE TO EXPLANT. THE SURGEON PLANS TO IMPLANT ANOTHER ICL LENS. THE CAUSE OF THE EVENT WAS DUE TO OVERSIZED LENS. THE PATIENT CONDITION AT ONE DAY POST-OP, MILD CORNEAL EDEMA AND ANGLE OPEN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8511516 ↗

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