Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103176)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542103176), received between Jun 9, 2017 and Feb 23, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2022Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -04.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD). THE LENS WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588748 ↗
• InjuryFeb 23, 2022Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -04.00 DIOPTER, IN THE PATIENTS EYE. THE LENS WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588744 ↗
• InjuryMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A 13.2MM, MICL13.2,-4.0 DIOPTER, IMPLANTABLE COLLAMER LENS, WAS RETURNED UNDAMAGED. NOTE ON THE LENS PACKAGING BOX INDICATED "(OS)OPENED, IMPLANTED, EXCHANGED". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 7509058 ↗
• InjuryMar 8, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT HE IMPLANTED A 13.2 MM MICL13.2, -4.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT RIGHT EYE (OD) ON (B)(6) 2018. ON POST OP DAY 1 EXCESSIVE VAULT, ELEVATED IOP AND ANGLE CLOSURE WAS DISCOVERED. THE PATIENT WAS PLACED ON COMBIGAN TO LOWER IOP. AT DAY 3 AND 5 THE ELEVATED VAULT PERSISTED WITH NARROWING OF THE ANGLE. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE REPORTED STATED THAT THE PATIENT IS HAPPY WITH GOOD CURRENT VISION.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 7324462 ↗
• MalfunctionJan 12, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE REPORTER INDICATED THAT THE SURGEON NOTICED MICROSCOPIC BLACK FLAKES ON A MICL13.2, -4.0 DIOPTER, IMPLANTABLE COLLAMER LENS WHEN THEY OPENED THE LENS VIAL AND WERE PREPARING TO LOAD THE LENS IN THE CARTRIDGE FOR THE INJECTION ON (B)(6) 2017. THE SURGEON DESCRIBED OPENING THE LENS VIAL WITH HEMOSTATS, REMOVING THE METAL RING, AND REMOVING THE GREY STOPPER WITH A STERILE GLOVED HAND. THE LENS WAS POURED OUT OF THE VIAL ONTO THE INJECTOR CARTRIDGE TRAY WITH THE ASSISTANCE OF THE INJECTOR PLUNGER TO GUIDE THE LENS OUT OF THE VIAL. WHEN THE LENS WAS PICKED UP WITH ICL LOADING FORCEPS, THE BLACK FLAKES WERE NOTICED. THERE WAS NO PATIENT CONTACT. THEY USED A NEW CARTRIDGE/INJECTOR AND A NEW ICL WAS LOADED AND USED TO PERFORM THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7188510 ↗
• InjuryJun 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -4.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD). THE REPORTER INDICATED THE SURGEON IS PLANNING TO EXPLANT THE LENS AT A LATER DATE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available; No Information

  MAUDE report 6632235 ↗

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-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-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.
• 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.