EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-5.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840311304370), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 injury.

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.

• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS ONE OF FIVE THAT ARE REPORTING THE SAME ISSUE OF POTENTIAL TASS OBSERVED ONLY IN ONE CASE BUT COULD NOT BE SEPARATED DUE TO LACK OF ADDITIONAL INFORMATION. THE REPORTER INDICATED THAT THE SURGEON IMPLANTED 12.1MM VTICM5 12.1 OF DIOPTER -5.50/1.0/059 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE DURING THE WEEK OF (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE LIOLI-24 INJECTOR AND OCUCOAT OVD. ONE CASE WAS ASSESSED AS POTENTIAL TASS BUT WAS NOT SPECIFIED BY RECEIVED SERIAL NUMBERS OF 5 LENSES. I N ALL CASES INTRAOPERATIVELY THE ICL LOOKED LIKE THERE WERE DEPOSITS ON IT AND AT THE SAME DAY POST-OP CHECK ICL LOOKED LIKE IT HAD STREAKS ON IT. IN ONE CASE THERE WAS AN OBSERVATION OF" ALMOST GLITTERY APPEARANCE WITH SOME DEPOSITS ON THE ANTERIOR CRYSTALLINE CAPSULES". REPORTEDLY, DEPOSITS/STREAKS HAVE DISAPPEARED ON THEIR OWN WITHIN 24 HOURS. NO ABNORMALITIES WERE NOTED WITH THE ICL VIAL PRIOR TO LENS IMPLANTATION. TWO SURGEONS FROM THE SAME CLINIC HAD A "COUPLE OF ICL CASES" OF SIMILAR PRESENTATION WITHIN THE SAME THAT WEEK AND ONE OF THEM HAD OBSERVATIONS FOR CARTRIDGES "FEEL A BIT TIGHTER" AS WELL AS THAT OCUCOAT CANNULAS LOOK LIKE" THEY HAVE SOME

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20163962 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.