Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102995)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542102995), received between Dec 23, 2015 and Feb 8, 2022 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6; -8.5 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S EYE. THE PATIENT HAD INTRAOCULAR PRESSURE SPIKES AND THE SURGEON HAD TO PERFORMED AN EMERGENCY PERIPHERAL IRIDOTOMY. IT WAS ALSO NOTED THEY BELIEVE THE LENS IS TOO LARGE FOR THE PATIENT'S EYE AND CALCULATIONS WILL BE PERFORMED TO ORDER A NEW LENS SIZE BEFORE IMPLANTING INTO THE PATIENT. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 13488086 ↗
• MalfunctionSep 21, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS REMOVED AND REPLACED WITHIN THE SAME SURGERY DUE TO THE LENS FLIPPING OVER IN THE EYE. THERE WAS NO PATIENT INJURY AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10563730 ↗
• InjuryApr 6, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE SURGEON INDICATED THAT HE IMPLANTED A 12.6MM MICL12.6, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 IRITIS WAS OBSERVED. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO PERSISTENT IRITIS AND HIGH IOP (INTRAOCULAR PRESSURE). THE SURGEON REPORTED TO USE COMBIGAN, DUREZOL, PRED FORTE, AND LOTEMAX OVER THE COURSE OF TREATMENT. IT WAS REPORTED THAT AN IRIDECTOMY WAS PERFORMED. THE SURGEON REPORTED THAT HE BELIEVED THE CAUSE OF THE IRITIS WAS PIGMENT DISPERSION FROM ICL CHAFING OF POSTERIOR IRIS. ON (B)(6) 2018 THE SURGEON REPORTED THAT HE WAS NOT CERTAIN OF WHY THE INFLAMMATION CONTINUED. HE STATED THAT THERE WERE SOME PIGMENTARY CELLS, BUT MOST WERE WHITE CELLS AND THAT THE LENS SIZING WAS CORRECT. HE STATED THAT THE PATIENT IS DOING WELL IN SOFT CONTACT LENSES, INFLAMMATION IS RESOLVING. HE ALSO REPORTED THAT THEY WILL BE PERFORMING A PROPER FITTING FOR THE PATIENT IN THE FUTURE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; Iritis; No Code Available

  MAUDE report 7404316 ↗
• InjuryMar 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018, THE LENS WAS EXPLANTED DUE TO NARROW ANGLES. THERE WAS NO PATIENT INJURY. THERE IS NO PLANS TO IMPLANT ANOTHER LENS IN THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 7359033 ↗
• MalfunctionFeb 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTEDLY, A 12.6MM MICL12.6, DIOPTER -8.5 IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2017. IT WAS REMOVED INTRAOPERATIVELY DUE TO THE PUPIL WOULD NOT CONSTRICT AS APPROPRIATE. ON (B)(6) 2018 AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED. THE PROBLEM IS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 7267535 ↗
• MalfunctionJun 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, AND THE LENS TORE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675642 ↗
• InjuryApr 5, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, DURING THE SAME SURGERY DUE TO THE LENS STARTED TO VAULT AND WAS TOO LONG. THE CHAMBER WAS SHALLOW AND THE IRIS HAD BEGUN TO PROLAPSE THROUGH THE INCISION. THE LENS WAS REMOVED WITH NO PATIENT COMPLICATIONS. THERE WAS IRIS ATROPHY AND SOME CORNEAL EDEMA. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. AFTER A WEEK, THE PATIENT HAD IMPROVED AND VA WAS 20/25. THE REPORTER STATED THE EVENT WAS DUE TO A SIZING ISSUE.

  Patient problems: Corneal Edema; No Code Available; Prolapse

  MAUDE report 6462705 ↗
• MalfunctionOct 28, 2016Positioning Failure; Torn Material; Positioning Failure; Torn Material

  THE REPORTER STATED THE SURGEON WAS INSERTING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, AND NOTED THE LENS WAS DAMAGED. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE LENS MAY NOT HAVE BEEN PULLED DOWN THE CARTRIDGE BARREL ENOUGH AND THE FOAM TIP PLUNGER CAUGHT AND DAMAGED THE LENS. THE REPORTER STATED THE CAUSE OF THE EVENT WAS DUE TO USER ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6064990 ↗
• InjuryJul 20, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO THE LENS HAD A REFRACTIVE SURPRISE. 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

  MAUDE report 5810890 ↗
• MalfunctionJun 1, 2016Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, AND THE LENS WOULD NOT UNFOLD IN THE PATIENT'S EYE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5693629 ↗
• MalfunctionDec 23, 2015Unintended Movement

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER BUT THE LENS WAS INSERTED INTO THE EYE UPSIDE DOWN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5323184 ↗

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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.