Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542103190), received between May 13, 2016 and Mar 25, 2022 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS -5.0 DIOPTER TORE DURING LOADING. THIS OCCURRED ON (B)(6) 2022 THERE WAS NO PATIENT CONTACT WITH THE LENS AND A BACKUP LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13911621 ↗
• InjuryJun 17, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATES A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS -5.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE. REPORTEDLY THE LENS WAS VAULTED AND THEN WAS EXPLANTED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021865 ↗
• MalfunctionApr 12, 2021Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -05.00 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS WAS POSSIBLY INSERTED UPSIDE DOWN IN THE PATIENTS RIGHT EYE (OD). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS WITHIN THE SAME SURGERY AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT IS HEALING AND SEEING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648750 ↗
• InjuryMar 14, 2021Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -05.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO PATIENT EXPERIENCED A REFRACTIVE SURPRISE AND MONOCULAR DIPLOPIA (DOUBLE VISION). THE LENS WAS EXCHANGED FOR A TORIC ICL LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN, THERE WAS SOME RESIDUAL REFRACTIVE ERROR, BUT EVEN WITH GLASSES THE PATIENT HAD MONOCULAR DIPLOPIA, VERY SMALL PERIPHERAL PI UNLIKELY CAUSE. THE EYE IS NORMAL AND ACUITY AND SYMPTOMS IMPROVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11478820 ↗
• InjuryJan 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -5.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 9565826 ↗
• MalfunctionApr 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM, MICL13.2, -5.0 DIOPTER, IMPLANTABLE COLLAMER LENS, WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) BUT WOULD NOT OPEN UP/ UNABLE TO UNFOLD ONCE IMPLANTED. THE LENS WAS REMOVED AND RETRIED AT LEAST FOUR TIMES, USED OTHER LENS. NO PATIENT INJURY. 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 Consequences Or Impact To Patient

  MAUDE report 8501346 ↗
• InjuryJan 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 MICL13.2 IMPLANTABLE COLLAMER LENS, -5.0 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. ON (B)(6) 2018 THE SURGEON EXPLANTED THE LENS BECAUSE IT IS "TOO BIG" AND THE PATIENT IS UNCOMFORTABLE.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8254837 ↗
• MalfunctionJun 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON LOADED A 13.2MM MICL13.2, -5.0 DIOPTER, IMPLANTABLE COLLAMER LENS WRONG INTO THE CARTRIDGE. THE REPORTER STATED THAT IT WAS A LOADING ISSUE AND THAT CAUSE OF EVENT IS UNKNOWN. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AND THE BACKUP LENS WAS USED.

  Patient problems: No Patient Involvement

  MAUDE report 7648911 ↗
• InjuryJan 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.0 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2017 THE LENS WAS EXCHANGED FOR A LONGER LENS DUE TO "MALFUNCTIONING ICL WITH LOW VAULT."

  Patient problems: No Code Available

  MAUDE report 7201636 ↗
• InjuryApr 12, 2017Inadequacy 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, -5.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE PATIENT REPORTED HAD SEVERE PAIN BEHIND THE EYE AND FOREIGN BODY SENSATION. THE LENS REMAINS IMPLANTED BUT THE PLAN IS TO EXPLANT AND EXCHANGE FOR A SHORTER LENS.

  Patient problems: Foreign Body Sensation in Eye; Pain

  MAUDE report 6487472 ↗
• MalfunctionMar 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON LOADED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.0 DIOPTER, INTO THE CARTRIDGE BUT DID NOT LIKE HOW THE LENS WAS LOADED, HE FELT THERE WAS SOMETHING WRONG WITH THE LENS. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. 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 6408307 ↗
• InjuryMay 13, 2016Difficult To Position; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Difficult To Position; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.0 DIOPTER, AND NOTED THE LENS WAS TOO LONG FOR THE PATIENT'S EYE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. ANOTHER LENS WAS NOT IMPLANTED. THE SURGEON FELT THE LENS MAY HAVE BEEN MISLABELED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 5654689 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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.
• 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.