Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103589)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542103589), received between Nov 17, 2016 and Feb 4, 2020 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2020Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2020. ON (B)(6) 2020 THE SURGEON EXCHANGED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 9668836 ↗
• InjuryAug 1, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.7MM, MICL13.7, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE AND TWO WEEKS LATER THE SURGEON EXCHANGED THE LENS FOR A SHORTER LENGTH LENS DUE TO VAULT, LENS WAS TOO LARGE. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 8852692 ↗
• MalfunctionSep 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7 MM MICL 13.7 , -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) AND REMOVED IT ON (B)(6) 2018. DURING INITIAL SURGERY DUE TO OBSERVATION OF EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE EXCHANGE RESOLVED THE PROBLEM. ADDITIONAL INFORMATION REPORTED; PATIENT HAS RESIDUAL ASTIGMATISM WITH PLANS FOR PRK (PHOTOREFRACTIVE KERATECTOMY) IN 1 MONTH.

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

  MAUDE report 7890067 ↗
• InjuryJun 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM, MICL13.7, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED AND EXCHANGED FOR A SHORTER LENGTH AND DIFFERENT DIOPTER LENS DUE TO OBSERVATION OF EXCESSIVE VAULT AND REFRACTIVE SURPRISE. THIS EXCHANGE RESOLVED THE PROBLEM. PROGRESSIVE MYOPIA WAS REPORTED AS A PRE-EXISTING CONDITIONS.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7597627 ↗
• InjuryAug 2, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, DIOPTER -11.0, INTO THE PATIENT'S EYE. ON (B)(6) 2017 THE LENS WAS EXCHANGED FOR A SHORTER LENS DUE TO EXCESSIVE VAULTING, ELEVATED IOP, AND ANGLE CLOSURE. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; No Code Available; Pain; Pupillary Block

  MAUDE report 6762431 ↗
• MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, AND THE SURGEON NOTED THE LENS HAD TORN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6111700 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.