Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103336)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00841542103336), received between Jun 29, 2016 and Nov 6, 2021 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (9 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.

• InjuryNov 6, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE REPORTER STATES A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS -12.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE. REPORTEDLY ON THE LENS WAS EXPLANTED DUE TO IT BEING FLIPPED IN THE EYE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755766 ↗
• InjuryJul 14, 2021Inadequacy 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, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE, TOO LARGE/LONG.

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

  MAUDE report 12167107 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL 13.2, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. REPORTEDLY, LENS IS TOO BIG AND CAUSING NARROW ANGLES. SURGEON WOULD LIKE TO EXCHANGE FOR A SHORTER LENGTH LENS. LENS REMAINS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11651548 ↗
• MalfunctionFeb 18, 2021Improper or Incorrect Procedure or Method; Unintended Movement; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Unintended Movement; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED UPSIDE DOWN A 13.2MM MICL13.2, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY ON (B)(6) 2021 WITH A BACK-UP LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS USER ERROR. REPORTEDLY, "INITIAL LENS FLIPPED UPSIDE DOWN UPON INSERTION INTO EYE. NECESSARY TO REMOVE FROM EYE AND AT THAT POINT, A TEAR WAS NOTED ON PLATE OF HAPTIC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343191 ↗
• InjuryOct 15, 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, -12.0 DIOPTER, INTO THE PATIENT'S EYE. THE SURGEON EXPLANTED THE LENS BECAUSE IT IS TOO BIG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10687736 ↗
• InjuryApr 22, 2020Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE SURGEON HAD PERFORMED A LIMBAL RELAXING INCISION BUT IT WAS LEAKING SO THE SURGEON SUTURED THE INCISION CLOSED. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. POST-OP, THERE WAS IMPROVED VISION AND VAULT BUT WITH MYDRIASIS AT DAY ONE AND PATIENT COMPLAINED OF HALOS. INTRAOCULAR PRESSURE WAS ELEVATED BUT WAS TREATED AGGRESSIVELY WITH DIAMOX AND TOPICAL DROPS. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Halo; Intraocular Pressure Increased; No Code Available

  MAUDE report 9988375 ↗
• MalfunctionJan 20, 2020Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, MICL 13.2, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS HAD A TORN HAPTIC. 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 Known Impact Or Consequence To Patient

  MAUDE report 9608206 ↗
• MalfunctionMay 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2019 THE SURGEON FELT THAT THE INJECTOR WAS "BINDING" WHEN HE TRIED TO ADVANCE THE FOAM TIP PLUNGER AND WAS CONCERNED THE 13.2MM, MICL 13.2, IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER WAS "STUCK." SURGEON EXTRUDED THE LENS, "THOUGHT HE SAW A SMALL TEAR IN THE LENS AND DECIDED TO USE THE BACK UP LENS." THERE WAS NO PATIENT CONTACT WITH THE LENS. THE PATIENT IS DOING WELL POSTOPERATIVELY WITH UNCORRECTED VISION OF 20/20.

  Patient problems: No Patient Involvement

  MAUDE report 8625107 ↗
• InjuryDec 12, 2018Inadequacy 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, -12.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED AND EXCHANGED WITHIN THE SAME SURGERY, ON (B)(6) 2018 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 8158097 ↗
• InjuryAug 10, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO MODERATELY HIGH VAULTING AND NIGHT GLARE. THE LENS WAS REPLACED WITH ANOTHER ICL LENS. THERE WAS NO PATIENT INJURY. 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; Visual Disturbances

  MAUDE report 7773012 ↗
• InjuryJun 22, 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, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED DUE TO OBSERVATION OF EXCESSIVE VAULT, ELEVATED IOP (INTRAOCULAR PRESSURE), SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, PIGMENT DISPERSION, AND GLARE/HALOES. ADDITIONAL SURGICAL INTERVENTION (ENLARGEMENT AND ADDITION OF NEW PI) WERE PERFORMED. ADDITIONAL INFORMATION REPORTED; DECREASED CELL AND FLARE + REMOVAL. PATIENT REPORTS DECREASE IN GLARE.

  Patient problems: Halo; Intraocular Pressure Increased; No Code Available; No Consequences Or Impact To Patient; Visual Disturbances

  MAUDE report 7631451 ↗
• InjurySep 12, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.2, -12.0 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, (PUPILLARY BLOCK) ELEVATED IOP, NARROWING OF THE ANGLE, ANGLE CLOSURE, SHALLOWING OF THE ACD, ANTERIOR LENS OPACITY, WATER VACUOLES, AND FIXED DILATED PUPIL. THE LENS WAS EXCHANGED. A POSSIBLE IRIDOPLASTY IS PLANNED.

  Patient problems: Cataract; Intraocular Pressure Increased; No Code Available; Pupillary Block

  MAUDE report 6859975 ↗
• InjuryApr 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE REPORTER INDICATED THE PATIENT WAS EXPERIENCING GLARE AND HALOS, WORSE IN AM AND AT NIGHT. THE PATIENTS PUPILS ARE 6.5MM IN DIM ILLUMINATION, ARE ESSENTIALLY EQUAL IN SIZE AND THERE IS NO EVIDENCE OF TRAUMATIC MYDRIASIS. THE PATIENT IS BEING TREATED WITH DROPS AND THE LENS REMAINS IMPLANTED. THE PATIENTS VISION IS 20/20 UNCORRECTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 6521056 ↗
• InjuryMar 23, 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, -12.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE. THE PATIENT EXPERIENCED BLURRED VISION AND PAIN. A SHORTER LENS WAS IMPLANTED ON (B)(6) 2017 AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 6430437 ↗
• MalfunctionNov 2, 2016Torn Material; Torn Material

  THE REPORTER STATED THAT A 13.2MM MICL13.2 LENS, -12.00 DIOPTER, TORE DURING LOADING ON (B)(6) 2016. THERE WAS NO PATIENT CONTACT AND A BACKUP LENS WAS USED. THE CAUSE OF THE TEAR IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6074378 ↗
• InjurySep 28, 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, -12.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. AT A POST-OP VISIT ON (B)(6) 2016, THE SURGEON NOTED AN INCREASE IN THE OCULAR PRESSURE AND LENS WAS CLOUDY. THE SURGEON ATTEMPTED TO RE-POSITION THE LENS BUT WITH NO SUCCESS. THE LENS WAS EXPLANTED AND A SHORTER LENS WAS IMPLANTED. THERE WERE NO COMPLICATIONS.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 5983954 ↗
• MalfunctionJun 29, 2016Torn Material; Torn Material

  THE REPORTER STATED SHE WAS ADVANCING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, FORWARD FROM THE CARTRIDGE WITH A FORCEP ON (B)(6) 2016 AND THE LENS TORE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5758686 ↗

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-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-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.
• 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.