Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542103091), received between Jan 26, 2016 and Oct 29, 2021 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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.

• MalfunctionOct 29, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED THAT A 12.6MM, MICL12.6, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12717074 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATES A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS -13.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. REPORTEDLY ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO A CATARACT FORMING.

  Patient problems: Cataract

  MAUDE report 12523570 ↗
• MalfunctionSep 23, 2021Misfocusing; Misfocusing

  THE REPORTER STATES A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS -13.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. THE SURGEON REPORTS REFRACTIVE ERROR.

  Patient problems: Blurred Vision

  MAUDE report 12523480 ↗
• MalfunctionNov 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE PLUNGER KEPT DRAGGING AND PULLING A 12.6MM, MICL12.6, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS. THE LENS WOULD NOT FULLY INSERT AND THEN IT TORE. THERE WAS NO PATIENT CONTACT. LENS WAS SHREDDED INTO LITTLE PIECES AND DISCARDED. 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 Patient Involvement

  MAUDE report 9372698 ↗
• MalfunctionNov 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE PLUNGER KEPT DRAGGING AND PULLING A 12.6MM, MICL12.6, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS. THE LENS WOULD NOT FULLY INSERT AND THEN IT TORE. THERE WAS NO PATIENT CONTACT. 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 Patient Involvement

  MAUDE report 9372551 ↗
• MalfunctionNov 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -13.5 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) AS A REPLACEMENT LENS BUT IT DID NOT RESOLVE THE PROBLEM COMPLETELY. THE AC (ANTERIOR CHAMBER) REMAINS VERY SHALLOW, BUT IT IS NO LONGER EXTREMELY SHALLOW AND THREATENING THE CORNEAL ENDOTHELIUM. EVEN WITH A SMALLER LENS THAN CALL FOR (DESPITE REPEAT CONFIRMATION OF CORRECT WTW) THE NEW SMALLER LENS REMAIN EXCESSIVELY VAULTED. THE PATIENT IS DOING VERY WELL. PATIENT IS HAPPY WITH HER VISION AND HER IOP (INTRAOCULAR PRESSURE) IS NORMAL. SURGEON WILL CONTINUE TO MONITOR THE LENS POSITION, CORNEAL HEALTH AND IOP (INTRAOCULAR PRESSURE).

  Patient problems: No Code Available

  MAUDE report 8040111 ↗
• MalfunctionSep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED SURGEON LOADED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, AND NOTED THE LENS WAS WRINKLED. THE SURGEON DECIDED NOT TO USE THE LENS AND REQUESTED THE BACKUP LENS, WHICH WAS IMPLANTED WITH NO PROBLEM. THERE WAS NO PATIENT CONTACT AND THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6853773 ↗
• MalfunctionSep 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON WAS ABOUT TO IMPLANT A MICL12.6, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE. WHILE THE LENS WAS BEING LOADED, THE LENS TORE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6845961 ↗
• InjuryJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED, PRIOR TO INSERTION OF A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, THE SURGEON MADE THE INCISION AND ACCIDENTLY NICKED THE CAPSULE BAG. THE SURGEON INSERTED THE LENS INTO THE PATIENT'S RIGHT EYE (OD), AND NOTED THE NICK IN THE BAG. THE PATIENT WAS SENT TO ANOTHER FACILITY THE SAME DAY, FOR REMOVAL OF THE LENS. THE LENS WAS EXPLANTED AND AN IOL WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 6679407 ↗
• InjuryApr 6, 2016Unintended Movement; Unintended Movement

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, AND THE LENS WAS NOTED TO BE UPSIDE DOWN IN THE PATIENT'S EYE. THE SURGEON HAD SOME DIFFICULTY REMOVING THE LENS DURING THE SAME SURGERY BUT THERE WAS NO PATIENT INJURY. THE SURGEON DECIDED NOT TO IMPLANT ANOTHER MICL LENS AT THAT TIME AND THE SURGERY WAS ABORTED. ANOTHER MICL LENS WAS IMPLANTED AT A LATER DATE WITH NO PROBLEM AND THE PATIENT IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5553065 ↗
• MalfunctionJan 26, 2016Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, WAS REMOVED FROM THE LENS VIAL AND THE SURGEON WAS PREPARING TO LOAD THE LENS. A BLACK SPECK WAS NOTED ON THE LENS AND THE SURGEON DECIDED NOT TO USE IT. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 5392219 ↗

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-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-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-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.