Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00841542103053), received between Aug 11, 2016 and Jun 9, 2022 — classified as 6 injuries, 11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 -11.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022 AS A REPLACEMENT LENS TO ADDRESS EXCESSIVE VAULT, PUPIL BLOCK, ANGLE CLOSURE, ELEVATED INTRAOCULAR PRESSURE, UNREACTIVE (FIXED) PUPIL, AND BLURRED VISION. IT WAS REPORTED THAT THIS REPLACEMENT LENS RESOLVED THE PROBLEM. HOWEVER, IT WAS ALSO REPORTED THAT THE VAULT WAS STILL HIGH. PER UPDATED INFORMATION THE REPORTER STATED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. VAULT HAS RESOLVED ON ITS OWN. FOR PATIENTS CURRENT CONDITION THE REPORTER REPORTED" PT IS 20/20 OU, STABLE EYE PRESSURE, COMFORTABLE, AND DOING WELL OU. VAULT HAS REDUCED FROM PREVIOUSLY NOTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651200 ↗
• InjuryApr 26, 2022Adverse 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; -11.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED ANGLE CLOSURE WITH ELEVATED INTRAOCULAR PRESSURE. ON (B)(6) 2022 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 14215323 ↗
• MalfunctionMar 23, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.50 DIOPTER, WAS OPENED AND NOT USED, WITH NO PATIENT CONTACT. THE LENS WAS RETURNED TO THE MANUFACTURER AND WAS FOUND TO BE DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556798 ↗
• MalfunctionMar 22, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.50 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS TORE DURING INSERTION. THERE WAS NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547873 ↗
• MalfunctionJan 21, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2020 A MICL 12.6, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE BEFORE/DURING LOADING. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. A BACKUP LENS WAS IMPLANTED INTRAOPERATIVELY AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS LOADING ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206968 ↗
• MalfunctionAug 13, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE A 12.6MM MICL12.6, -11.5 DIOPTER, IMPLANTABLE COLANDER LENS, MEANT FOR THE PATIENT'S EYE ON (B)(6) 2020 HAD "A BROWN SPOT ON THE LENS. LENS WAS NEVER INSERTED, BACK-UP LENS IMPLANTED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE. REPORTEDLY, PATIENT IS "RECOVERING AT A NORMAL RATE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10404418 ↗
• MalfunctionJul 28, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, 11.5 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. AFTER INSERTION, THE LENS "FLIPPED IN THE EYE." INTRAOPERATIVELY, THE LENS WAS SUCCESSFULLY REMOVED AND EXCHANGED WITH AN ALTERNATE LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10332985 ↗
• InjuryFeb 28, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, - 11.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2019. AT ONE-DAY POST-OP, THE PATIENT REPORTED EYE PAIN, WHICH WAS NOT RESOLVED WITH ARTIFICIAL TEARS OR WARM COMPRESSES. THE PATIENT GOT A SECOND OPINION BUT WAS UNABLE TO SOLVE THE SOURCE OF THE PAIN. THE PATIENT REQUESTED THE LENS BE REMOVED AND THE LENS WAS EXPLANTED ON (B)(6) 2020. THERE ARE NO PLANS TO IMPLANT ANOTHER ICL LENS. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT REPORTED POST-OP, HER EYE PRESSURE HAD INCREASED AND WAS TREATED WITH COMBIGAN. WAS ALSO TREATED FOR DRY EYE FOR OVER A MONTH. THE PATIENT'S CURRENT CONDITION STILL HAS OCCASIONAL PAIN.

  Patient problems: Dry Eye(s); Intraocular Pressure Increased; No Code Available; Pain

  MAUDE report 9772182 ↗
• InjuryJan 29, 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 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED DUE TO INCREASED POST-OP PRESSURE. ON (B)(6) 2019 A SHORTER LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. NO PATIENT INJURY IS NOTED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8287616 ↗
• InjuryJan 10, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND WAS EXCHANGED FOR A LONGER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8233832 ↗
• MalfunctionDec 28, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, WAS TORN DURING THE LOADING PROCESS, AS THE LENS WAS BEING PULLED THROUGH THE CARTRIDGE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8204888 ↗
• MalfunctionMay 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7520052 ↗
• MalfunctionMar 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON LOADED A 12.6MM MICL12.6, IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, AND THE LENS RIPPED. THERE WAS NO PATIENT CONTACT. THE BACK UP LENS WAS USED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7382965 ↗
• InjuryFeb 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE REPORTER STATED THAT HALOES AND INCREASE IN FLOATERS WERE NOTICED. ATTEMPT TO OBTAIN ADDITION INFORMATION WAS UNSUCCESSFUL.

  Patient problems: Halo; No Code Available

  MAUDE report 7248713 ↗
• InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO THE LENS WAS NOT POSITIONED CORRECTLY IN THE EYE. THERE WAS NO PATIENT INJURY. THE LENS WAS EXCHANGED WITH ANOTHER SAME MODEL/LENGTH/ DIOPTER LENS AND THE PROBLEM WAS RESOLVED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN BUT THERE WAS NO ISSUE WITH THE LENS OR PATIENT.

  Patient problems: No Code Available

  MAUDE report 6595986 ↗
• MalfunctionMay 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL12.6, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THE REPORTER CONFIRMED THAT IT WAS NOT DUE TO USER OR TECHNICIAN ERROR AND THAT "THE LOADER TORE THE LENS". THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6552491 ↗
• MalfunctionAug 11, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, AND THE LENS HAPTIC WAS NOTED TO BE DAMAGED. 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 5870490 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.