Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103244)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00841542103244), received between Jan 20, 2017 and Jul 8, 2021 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE REPORTER INDICATED THE SURGEON PLANS TO EXPLANT AND EXCHANGE THE LENS FOR A SHORTER LENS. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140355 ↗
• InjuryJun 23, 2021Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 AND EXCHANGED FOR A SHORTER LENS. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052902 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS EXPLANTED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11563276 ↗
• InjurySep 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL 13.2, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2019. THE LENS WAS REMOVED AND REPLACED ON (B)(6) 2019 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. 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 9070258 ↗
• MalfunctionAug 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO LOAD A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, IT TORE. THE SURGEON REPORTS THAT HE FELT LIKE HE HAD APPROPRIATELY GRASPED THE LENS BUT THE EDGE RIPPED WHEN PULLING IT THROUGH. THIS OCCURRED ON (B)(6) 2019. THERE WAS NO PATIENT CONTACT WITH THE LENS.

  Patient problems: No Patient Involvement

  MAUDE report 8941319 ↗
• MalfunctionFeb 26, 2019Unintended Movement; Unintended Movement

  A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, WAS REQUESTED TO BE RETURNED WITH THE INFORMATION "LENS FLIPPED, NOT IMPLANTED." DATE OF SCHEDULED SURGERY WAS (B)(6) 2019. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372530 ↗
• InjuryDec 13, 2018Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. EXCESSIVE VAULT, LEADING TO CORNEAL DECOMPENSATION, UNCONTROLLED IOP, NARROWING OF THE ANGLES, CORNEAL EDEMA, AND SHALLOWING OF THE ACD WAS OBSERVED. PAIN AND BLURRY VISION WAS REPORTED AS ADDITIONAL SYMPTOMS. ADDITIONAL SURGICAL INTERVENTION ( AC WASHOUT, ICL "REPOSTIONING", REPEAT YAG PI) WAS PERFORMED. IT WAS REPORTED THAT IOP LOWERING DROPS AND PILLS WERE PRESCRIBED. THE LENS WAS EXPLANTED ON (B)(6) 2018. THE EXPLANT RESOLVED THE HIGH VAULT AND IOP. PATIENT IS DOING BETTER BUT DOES HAVE PIGMENT ON ENDOTHELIUM, AND MILD MYDRIASIS, LIKELY CONTRIBUTING TO GLARE COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Corneal Decompensation; Corneal Edema; Inflammation; Intraocular Pressure Increased; No Code Available; Pain; Visual Disturbances

  MAUDE report 8159607 ↗
• MalfunctionAug 15, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED THAT 13.2MM MICL13.2, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS FLIPPED UPSIDE DOWN IN THE EYE WHEN IT CAME OUT OF THE INJECTOR. THE LENS WAS REMOVED AND THE BACKUP LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THERE WAS NO PATIENT INJURY AND THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787039 ↗
• InjuryAug 10, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM, MICL13.2. -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS ON (B)(6) 2018. THE LENS WAS REMOVED ON (B)(6) 2018 DUE TO LENGTH AND A SHORTER LENGTH LENS WAS IMPLANTED. 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 7774598 ↗
• MalfunctionMar 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON PARTIALLY LOADED A MICL13.2 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, IN THE CARTRIDGE AND DECIDED TO GO WITH THE BACKUP LENS. IT WAS REPORTED THAT THE DOCTOR INSPECTED THE LENS UNDER A MICROSCOPE AND DID NOT LIKE HOW IT LOOKED, POSSIBLE FLAW IN THE LENS. NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7308338 ↗
• InjuryOct 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS. 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 6950033 ↗
• InjuryAug 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MICL13.2, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE PATIENT EXPERIENCED RECURRING IRITIS, IRIS CHAFFING, AND REDNESS IN EYE. THE LENS WAS EXPLANTED ON (B)(6) 2017. ADDITION OF SUTURE WAS ALSO PERFORMED. THE SURGEON DOES NOT PLAN TO IMPLANT ANOTHER LENS. THE CURRENT CONDITION OF THE PATIENT IS THAT SHE HAS VITREOUS BLEED. THE RETINA WAS EVALUATED AND THE SURGEON BELIEVES IT WILL MAKE A FULL RECOVERY. THERAPY FOR IRIS REPAIR AND POSSIBLE VITRECTOMY IS PLANNED.

  Patient problems: Iritis; No Code Available; Red Eye(s)

  MAUDE report 6786750 ↗
• MalfunctionJan 31, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, AND NOTICED THE LENS WAS INJECTED IN THE EYE UPSIDE DOWN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. THE BACK UP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTED STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6290872 ↗
• InjuryJan 20, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS. 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 6268524 ↗

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