Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102957)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542102957), received between Sep 16, 2016 and Nov 11, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE AND BLURRED VISION. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision

  MAUDE report 15784581 ↗
• InjuryNov 17, 2021Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REMOVED ON (B)(6) 2021 DUE TO THE LENS WAS TOO BIG. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833407 ↗
• InjuryAug 13, 2019Adverse 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, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S EYE ON (B)(6) 2019. REPORTEDLY, "PATIENT WANTED BETTER NEAR VISION IN EYE AND SOME ASTIGMATISM WAS FOUND TO BE RELATED TO IT AS WELL." ON (B)(6) 2019 THE LENS WAS REMOVED AND EXCHANGED WITH A TORIC ICL. THIS RESOLVED THE PROBLEM. PER REPORTER ON (B)(6) 2019, "PATIENT IS HAPPY WITH VISION AND SAYS CONTINUALLY IMPROVING."

  Patient problems: Blurred Vision

  MAUDE report 8887955 ↗
• InjuryDec 13, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. DURING INSERTION, THE LENS INVERTED AND ROTATED. THE SURGEON HAD TO ENLARGE THE INCISION TO EXPLANT THE LENS. THE LENS WAS INTRAOPERATIVELY EXCHANGED WITH A BACK-UP LENS AND IT WAS SUCCESSFUL. THE PATIENT IS CURRENTLY FINE.

  Patient problems: No Code Available

  MAUDE report 7114231 ↗
• InjuryMay 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL12.6, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED DUE TO THE PATIENT DID NOT LIKE HOW THEY FELT AND DID NOT LIKE HAVING A PERMANENT LENS. THE LENS WAS EXPLANTED A COUPLE OF WEEKS AFTER IT WAS IMPLANTED. THE REPORTER STATED THE LENS WAS NOT DEFECTIVE AND THE PATIENT JUST DIDN'T LIKE THEM. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 6544381 ↗
• MalfunctionMar 29, 2017Difficult to Fold, Unfold or Collapse; Device Operates Differently Than Expected; Material Deformation; Difficult to Fold, Unfold or Collapse; Device Operates Differently Than Expected; Material Deformation

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, BUT THE LENS WOULD NOT UNFOLD. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. UPON REMOVAL, THE LENS HAPTIC WAS NOTED TO BE CURVED AND BENT UPWARDS. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT MAY HAVE BEEN DUE TO AGGRESSIVE MANIPULATION IN ORDER TO GET THE LENS TO UNFOLD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6444891 ↗
• MalfunctionFeb 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, WAS TORN DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE EVENT OCCURRED WHEN THE LENS WAS BEING PULLED INTO THE CARTRIDGE TIP BY THE POSITIONING FORCEPS. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION, SO THE CAUSE IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6341611 ↗
• InjurySep 16, 2016Unintended Movement; Appropriate Device Problem Term/Code Not Available; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. SOON AFTER, THE SURGEON REALIZED THE LENS WAS IMPLANTED UPSIDE DOWN. THE LENS WAS EXPLANTED ON (B)(6) 2016 WITH NO PATIENT INJURY AND WAS ACCIDENTLY DISCARDED. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 5957291 ↗

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