Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-8.5/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542108843), received between Mar 11, 2019 and Mar 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Ejection Problem” (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.

• MalfunctionMar 11, 2019Improper or Incorrect Procedure or Method; Ejection Problem; Improper or Incorrect Procedure or Method; Ejection Problem

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO IMPLANT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -8.5/+3.0/090 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD), THE LENS TORE. THERE WAS PATIENT CONTACT WITH THE LENS, WHICH WAS REMOVED INTRAOPERATIVELY ON (B)(6) 2019. LENS WAS NOT FULLY IMPLANTED. REPORTEDLY, THE SURGEON WAS NOT ADVANCING THE ICL TO THE TIP OF THE CARTRIDGE. WHEN HE PUSHED THE PLUNGER DOWN THE BARREL, IT OVERRODE THE ICL AND TRAPPED THE TRAILING HAPTICS IN THE TIP OF THE CARTRIDGE, TAKING A "BITE" OUT OF THE ICL. AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2019. THERE WAS NO PATIENT INJURY. REFERENCE MFR REPORT# 2023826-2019-00383 FOR BACK-UP LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409335 ↗
• MalfunctionMar 11, 2019Improper or Incorrect Procedure or Method; Ejection Problem; Improper or Incorrect Procedure or Method; Ejection Problem

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO IMPLANT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -8.5/+3.0/092 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD), THE LENS TORE. THERE WAS PATIENT CONTACT WITH THE LENS, WHICH WAS REMOVED INTRAOPERATIVELY ON (B)(6) 2019. LENS WAS NOT FULLY IMPLANTED. REPORTEDLY, THE SURGEON WAS NOT ADVANCING THE ICL TO THE TIP OF THE CARTRIDGE. WHEN HE PUSHED THE PLUNGER DOWN THE BARREL, IT OVERRODE THE ICL AND TRAPPED THE TRAILING HAPTICS IN THE TIP OF THE CARTRIDGE, TAKING A "BITE" OUT OF THE ICL. AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2019. THERE WAS NO PATIENT INJURY. REFERENCE MFR REPORT# 2023826-2019-00379 FOR PRIMARY LENS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409312 ↗

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-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.
• 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-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.