Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841542103060), received between Jul 12, 2016 and Aug 17, 2022 — classified as 10 injuries, 9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON LOADED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, AND NOTED IT WAS SCRATCHED. THERE WAS PATIENT CONTACT BUT NO COMPLICATIONS. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245947 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). IT WAS NOTED THAT "DESPITE DR. (B)(6) RECOMMENDING A TORIC ICL; SHE ELECTED AN SPHERICAL ICL. SHE NOW WANTS A TORIC ICL AND HAVE -1.00 TARGET IN BOTH EYES". THERE IS A PLANNED LENS EXCHANGE. LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14707046 ↗
• MalfunctionApr 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS OF -12.00 DIOPTER WAS BROKEN. " NOT USED AND NO PATIENT CONTACT" WAS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14062575 ↗
• MalfunctionApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S RIGHT EYE(OD) ON (B)(6) 2021. NARROW ANGLES ARE BEING OBSERVED. LENS REMAINS IMPLANTED AND PATIENT IS UNDER OBSERVATION. PER REPORTER ON (B)(6) 2021, "ANGLE HAS OPENED MORE AND THE PRESSURE IS STABILIZED TO NORMAL. THE SURGEON IS CLOSLY WATCHING THE PATIENT AND CHECKING ANGLES TO SEE IF THERE ARE IMPROVEMENTS OVERTIME AS THE EYE QUIETS DOWN. 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 11738951 ↗
• InjuryNov 28, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS FLIPPED AND DOCTOR TOOK A BITE OUT OF IT WHILE EXPLANTING. A BACK UP LENS WAS IMPLANTED. CORNEAL EDEMA WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Corneal Edema

  MAUDE report 10915417 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Optical Problem; Adverse Event Without Identified Device or Use Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON 06-APR-2020. AT ONE DAY POST-OP, THE VAULT AND VISION WAS IMPROVED BUT WITH MYDRIASIS AND HALOS. THE PATIENTS INTRAOCULAR PRESSURE WAS ELEVATED BUT WAS TREATED AGGRESSIVELY WITH DIAMOX AND TOPICAL DROPS. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2020-00945. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Intraocular Pressure Increased

  MAUDE report 10816077 ↗
• MalfunctionNov 4, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THEY WERE UNABLE TO LOAD A 12.6MM,MICL 12.6, -12.0 DIOPTER IMPLANTABLE COLLAMER LENS CORRECTLY. THERE WAS NO PATIENT CONTACT AND A BACKUP LENS WAS IMPLANTED. IN THE REPORTER OPINION THE CAUSE OF THIS EVENT IS THE INJECTOR, MODEL AND LOT NUMBERS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10788180 ↗
• InjuryJun 27, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING, PIGMENT DISPERSION AND ANTERIOR CHAMBER INFLAMMATION. THE REPORTER INDICATED THE EXCESSIVE VAULTING CAUSED PIGMENT DISPERSION (INCREASING INTRAOCULAR PRESSURE CONTROLLED ON DROPS AND HEAVY PIGMENT ON ICL), AND ANTERIOR CHAMBER INFLAMMATION SPIKES AS STEROIDS WERE TAPERED. THE PATIENT HAD CONSTANT ACHING SENSATION BUT THE PATIENT IS DOING WELL AT ONE-DAY POST-OP EXPLANT EXAM. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: Inflammation; Intraocular Pressure Increased; No Code Available; Uveitis

  MAUDE report 8742046 ↗
• InjuryApr 3, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER. THE LENS WAS EXPLANTED DUE TO THE LENS WAS TOO LONG AND ANGLE CLOSURE. THE LENS WAS EXCHANGED FOR A SHORTER 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 8480493 ↗
• MalfunctionMar 8, 2019Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED A 12.6MM, MICL12.6, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO PATIENTS EYE. THE SURGEON REPORTS EXCESSIVE VAULT, GLARE, AND HALOS. THE 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: Halo; Visual Disturbances

  MAUDE report 8403835 ↗
• MalfunctionSep 25, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, INTO THE PATIENT'S EYE ON (B)(6) 2018. INTRAOPERATIVELY, THE LENS WAS SUCCESSFULLY EXCHANGED WITH AN ALTERNATE LENS. THE REASON FOR THE EXCHANGE IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906909 ↗
• InjuryMar 20, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED. THE SURGEON NOTES ACUTE ENDOPHTHALMITIS WITH ACUTE IRITIS. REPORTEDLY, THE PATIENT HAS BEEN TREATED WITH AN INTRAOCULAR INJECTION AND TOPICAL DROPS INCLUDING ANTIBIOTICS. THE CLAIM REPORTER LISTS THE CAUSE OF THE ADVERSE EVENT AS HYPOTONY AND WOUND LEAKAGE. NO ADDITIONAL INFORMATION REGARDING PATIENT'S CURRENT STATUS IS KNOWN AT THIS TIME.

  Patient problems: Endophthalmitis; Intraocular Infection; Intraocular Pressure, Delayed, Uncontrolled; Iritis; No Code Available

  MAUDE report 7356138 ↗
• InjuryNov 28, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED DUE TO VAULTING. 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 7065636 ↗
• InjuryAug 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6 , -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. IT WAS NOTICED THAT THE HAPTIC OF THE LENS BROKE AND IT HAD TO BE EXPLANTED FROM THE EYE THE SAME DAY. A BACK-UP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 6836608 ↗
• MalfunctionApr 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON WAS LOADING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, AND THE LENS TORE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6473610 ↗
• MalfunctionMar 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON WAS LOADING A MICL12.6, -12.0 DIOPTER LENS AND NOTICED THE LENS WAS DAMAGED. HE DID NOT KNOW IF THE DAMAGE OCCURRED DURING THE LOADING PROCESS OR WHAT CAUSED THE DAMAGE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6415278 ↗
• MalfunctionAug 26, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, BUT THE SURGEON FELT THE LENS WAS NOT LOADED CORRECTLY, SO THE LENS WAS REMOVED. THERE WAS NO PATIENT INJURY AND THE BACKUP 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 Consequences Or Impact To Patient

  MAUDE report 5905512 ↗
• InjuryJul 27, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED DUE TO DEVELOPMENT OF A CATARACT. THE PATIENT'S NATURAL LENS WAS ALSO REMOVED AND REPLACED WITH A DIFFERENT INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Cataract, Induced; No Code Available

  MAUDE report 5826213 ↗
• InjuryJul 12, 2016Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO THE LENS BEING TOO LARGE AND HYPOTONY (LOW IOP). THE PATIENT EXPERIENCED BLURRED VISUAL ACUITY, EYE PAIN, HEADACHE, AND VOMITING. THE REPORTER INDICATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY (BCVA) WAS 20/25.

  Patient problems: Blurred Vision; Headache; No Code Available; Pain; Vomiting

  MAUDE report 5788401 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.