Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-6.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542108553), received between Sep 15, 2021 and Jan 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2022Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -6.50/+2.50/109 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE PATIENT EXPERIENCED EXCESSIVE VAULTING; BLURRY VISION AND THE LENS WAS EXCHANGED ON (B)(6) 2022 BUT THIS DID NOT RESOLVE THE PROBLEM. IT WAS LATER CLARIFIED THAT THE PATIENT STILL HAS FUZZY VISION; PUPILS ARE DILATED AND PRK SURGERY WAS PERFORMED. PATIENT STILL HAS BLURRY VISION. CAUSE OF THE EVENT WAS REPORTED AS "OTHER- UNEXPECTED SHORT CILLARY SULCUS SPACE". SEE MDR# 2023826-2022-00177 FOR REPLACEMENT LENS CLAIM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 13286578 ↗
• InjurySep 15, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.3MM, TMICL13.2, -6.5/2.5/91, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTOT THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. EXCESSIVE VAULT AND ANGLE CLOSURE WITH ELEVATED IOP WAS OBSERVED. IT WAS REPPORTED THAT MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. AC WASHOUT, VRT TAP AND SUTURE WOUND WAS REPORTED TO BE PERFORMED ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED. A LENS OF SHORTER LENGTH WAS LATER IMPLANTED AND IT WAS REPORTED THAT IT IS UNSURE YET IF THE PROBLEM RESOLVED. 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 SHALOW, DILATED IRIS." IT WAS ALSO REPORTED THAT LENSES MAY NEED TO BE REPLACED WITH SMALLER SIZE. CAUSE OF EVENT WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 12478337 ↗

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-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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.