Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542103183), received between Dec 13, 2016 and Oct 15, 2020 — classified as 7 injuries, 4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -4.5 DIOPTER FROM THE VIAL, THE LENS TORE. THIS OCCURRED ON (B)(6) 2020. THERE WAS NO PATIENT CONTACT WITH THE LENS AND A BACK-UP LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10687735 ↗
• InjuryApr 1, 2020Inadequacy 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, -4.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2020. ON THE SAME DATE, IN A SEPARATE SURGERY, THE SURGEON EXCHANGED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULT AND ELEVATED IOP. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS DEVICE "(SIZE)."

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9910966 ↗
• MalfunctionJul 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -4.5 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS TORE/BROKE DURING DELIVERY INTO THE EYE. THERE WAS NO PATIENT INJURY. A SAME MODEL/LENGTH/DIOPTER LENS WAS IMPLANTED WITHIN THE SAME SURGERY AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805166 ↗
• InjuryFeb 1, 2019Inadequacy 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, -4.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED DUE TO BEING TOO LARGE AND WAS EXCHANGED FOR A SHORTER LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8298713 ↗
• InjuryApr 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED A 13.2MM MICL13.2, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A LONGER LENS DUE TO LOW VAULT. THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 7404973 ↗
• InjuryMar 8, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT HE IMPLANTED A 13.2MM MICL13.2, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT LEFT EYE (OS) ON (B)(6) 2018. ON POST OP DAY 1 EXCESSIVE VAULT, ELEVATED IOP AND ANGLE CLOSURE WAS DISCOVERED. THE PATIENT WAS PLACED ON COMBIGAN TO LOWER IOP. AT DAY 3 AND 5 THE ELEVATED VAULT PERSISTED WITH NARROWING OF THE ANGLE. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE REPORTED STATED THAT THE PATIENT IS HAPPY WITH GOOD CURRENT VISION.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 7324571 ↗
• MalfunctionFeb 8, 2018Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT A MICL13.2, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS, WAS IMPLANTED UPSIDE DOWN IN THE PATIENTS RIGHT EYE (OD). THE LENS WAS REMOVED AND EXCHANGED WITH THE BACK UP LENS DURING THE SAME SURGERY. THERE WAS NO PATIENT INJURY AND IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7253425 ↗
• InjuryOct 25, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.2, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING, NARROWING OF THE ANGLE, AND SHALLOWING OF THE ACD. THERE IS NO PATIENT INJURY. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 6976662 ↗
• MalfunctionAug 30, 2017Positioning Failure; Positioning Failure

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -4.5 DIOPTER, AND THE LENS FLIPPED IN THE EYE. THE LENS WAS CUT IN HALF TO REMOVE AND THERE WAS NO PATIENT INJURY. THE BACK UP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6832456 ↗
• InjuryMar 27, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A MICL13.2 IMPLANTABLE COLLAMER LENS, -4.5 DIOPTER, IN THE PATIENT'S LEFT EYE ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULT AND SHALLOWING OF THE ACD AND EXCHANGED FOR A SMALLER LENS DURING THE SAME SURGERY. THERE WAS NO REPORTED PATIENT INJURY OR DIFFICULTIES OBSERVED DURING SURGERY. PATIENT'S POST-OP VA WAS 20/25. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 6437168 ↗
• InjuryDec 13, 2016Inadequacy 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, -4.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING AND ANGLE CLOSURE. THE PERIPHERAL IRIDOTOMIES WERE ENLARGED. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6172498 ↗

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