Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102964)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542102964), received between Aug 22, 2017 and Sep 24, 2022 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -7.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS OF DIFFERENT MODEL AND THE PROBLEM RESOLVED. " EXCELLENT VAULT POSITION" WAS REPORTED. IN THE REPORTER OPINION THE CAUSE OF EVENT WAS PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480367 ↗
• MalfunctionMar 24, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT UPON PULLING A 12.6MM, MICL12.6, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS THROUGH THE CARTRIDGE IT APPEARED THAT THE SHAPE OF THE "LEADING EYELET WAS NOT SMOOTH." IT WAS REPORTED THAT IT WAS NOTED AS THE LENS WAS BEING INJECTED INTO THE EYE, SO THE LENS AND CARTRIDGE WERE REMOVED FROM THE EYE AND THE BACKUP LENS WAS USED. DOCTOR WAS CONCERN THAT THE ROUGH EDGE COULD RUB AGAINST POSTERIOR IRIS TISSUE. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9875292 ↗
• InjuryAug 19, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD). THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO SIZING ISSUE, THE LENS WAS TOO LARGE. THE LENS WAS EXCHANGED FOR A SHORTER LENS. 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 8908380 ↗
• MalfunctionAug 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO LOW VAULT THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799160 ↗
• InjuryMay 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON THE SAME DAY, BUT DIFFERENT SURGERY. THE SURGEON WANTED TO "INCREASE THE STEEPNESS OF THE LENS" SO HE IMPLANTED ANOTHER LENS WITH A LONGER LENS. THE PROBLEM WAS RESOLVED. THE SURGEON THREW AWAY THE ORIGINAL LENS.

  Patient problems: No Code Available

  MAUDE report 7481814 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. WITHIN THE FIRST WEEKS FOLLOWING SURGERY AS THE EYE HEALED AND THE VISION NOT IMPROVING ACCORDINGLY, IT WAS DETERMINED THAT THE ICL HAD BEEN INSERTED UPSIDE DOWN. THE PATIENT UNDERWENT SUCCESSFUL REMOVAL AND IMPLANTATION OF A REPLACEMENT LENS ON (B)(6) 2018. IT IS REPORTED THAT SURGEON ERROR WAS THE CAUSE OF THE EVENT.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7207524 ↗
• MalfunctionSep 14, 2017Mechanical Jam; Mechanical Jam

  THE REPORTER INDICATED THAT ON (B)(6) 2017 AS THE SURGEON ATTEMPTED TO IMPLANT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, DIOPTER -7.0, INTO THE PATIENT'S LEFT (OS) EYE, IT GOT STUCK TO THE PLUNGER AND THE LENS BROKE. THERE WAS NO PATIENT CONTACT WITH THE LENS; BACK-UP LENS INSERTED DURING THE SAME SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864973 ↗
• InjuryAug 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, DIOPTER -7.0, INTO THE PATIENT'S LEFT (OS) EYE. ON (B)(6) 2017 THE LENS WAS EXCHANGED FOR A SHORTER AND SIMILAR DIOPTER LENS DUE TO ELEVATED IOP. THE PROBLEM IS RESOLVED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6812325 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.