Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103411)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00841542103411), received between Sep 22, 2016 and Apr 21, 2022 — classified as 14 injuries, 8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2022Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS OF -16.0 DIOPTER WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. ON (B)(4) 2022 THE LENS WAS REMOVED DUE TO LOW VAULT. UPON REMOVAL OF THE INITIAL LENS IT WAS DETERMINED TO FLIPPED INSIDE THE EYE. REPORTER STATES THERE WAS DIFFICULTY TUCKING HAPTICS UNDER THE IRIS AS THE MANIPULATOR CONSTANTLY STUCK TO THE ICL. ON THE SAME DAY DIFFERENT SURGERY A REPLACEMENT LENS OF SAME MODEL/SIZE AND DIOPTER WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. STATUS OF THE EYE REPORTED AS MODERATE ANTERIOR CELL. MILD CORNEAL EDEMA. PATENT PI. PER REPORTER "IT IS TYPICAL FOR ANY POST OPERATIVE EYE TO HAVE SOME CELL AND CORNEAL EDEMA, ESPECIALLY AFTER BEING OPERATED ON A SECOND TIME. THE PATENT PI IS ALSO NORMAL SINCE WE DID NOT HAVE AN EVO LENS SO WE HAD TO DO THE PI."

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

  MAUDE report 14178237 ↗
• MalfunctionAug 15, 2021Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.00 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS WAS IMPLANTED UPSIDE DOWN. THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITHIN THE SAME SURGERY WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE EYE WAS STABLE, WITH PIGMENT ON ENDO. THE CAUSE OF THE EVENT WAS DUE TO USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322433 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATES A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS -16.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT (OS) EYE. REPORTEDLY ON (B)(6) 2021 THE LENS WAS EXPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: Cataract; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215415 ↗
• InjuryJul 15, 2021Inadequacy 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 -16.0 DIOPTER INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, ANGLE CLOSURE, AND ELEVATED IOP. THE CAUSE OF THE EVENT IS REPORTED AS DEVICE: "DEVICE BEING TOO LARGE CAUSED ANTERIOR VAULT, RESULTING IN NARROWING ANTERIOR CHAMBER AND INCREASED IOP." THE PROBLEM IS RESOLVED WITH THE EXPLANT.

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

  MAUDE report 12178435 ↗
• InjuryMar 24, 2021Inadequacy 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, -16.00 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXCHANGED WITH A FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIEN-RELATED FACTOR,"LENS WAS TOO BIG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563266 ↗
• InjuryFeb 3, 2021Improper or Incorrect Procedure or Method; Unintended Movement; Improper or Incorrect Procedure or Method; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED UPSIDE DOWN A 13.2MM MICL13.2, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY, "SURGEON BELIEVES LENS INSERTED UPSIDE DOWN, WILL BE REPLACED WITH ANOTHER LENS." 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11273781 ↗
• InjuryOct 24, 2019Misfocusing; Material Opacification; Adverse Event Without Identified Device or Use Problem; Misfocusing; Material Opacification; Adverse Event Without Identified Device or Use Problem

  RECEIVED A VOLUNTARY EVENT REPORT FROM FDA: # MW5089673. THE PATIENT REPORTED ON (B)(6)2019, A "SERIOUS INJURY" REPORT WITH OUTCOME OF "DISABILITY/PERMANENT DAMAGE". THE PATIENT STATED "GOT VISIAN ICL PLASTIC LENS IMPLANTS IN BOTH EYES. IN LEFT EYE OVER A YEAR LATER I HAD SYMPTOMS OF FOGGY VISION, NEW FLOATERS AND TODAY MY VISION IS ALMOST GONE. THERE'S A HUGE BLOB OF WATER BLOCKING MY SIGHT. WHEN I MOVE MY EYE I CAN SEE THE WATER MOVE." PER THE SAME REPORT CONCOMITANT MEDICAL PRODUCTS LISTED AS: "ALPHAGAN AND PRENATAL VITAMINS", WITH PATIENT PROBLEMS OF: "IMPAIRED VISION, VITREOUS FLOATERS" AND DEVICE PROBLEMS: "ADVERSE EVENTS WITHOUT IDENTIFIED DEVICE OR USE PROBLEM" WAS REPORTED. PER PATIENT EMAIL OF 30 SEP 2019 "VISIAN ICL WAS REMOVED ON THE LEFT EYE (B)(6) TO PREPARE FOR VITRECTOMY FOR RETINAL DETACHMENT REPAIR". INFORMATION RECEIVED FROM THE IMPLANTING SURGEON INDICATED THAT A 13.2MM, MICL13.2, -16.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2017 AND REMOVED ON (B)(6) 2019. LOSS OF BCVA, LENS OPACITY (NS), RETINAL DETACHMENT, BLURRED VISION, AND FLOATERS WAS OBSERVED. ADDITIONAL SURGICAL INTERVENTION/TREATMENT (PRK, ICL REMOVA

  Patient problems: Blurred Vision; Cataract; No Code Available; Retinal Detachment; Visual Disturbances; Vitreous Floaters

  MAUDE report 9233429 ↗
• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, A 13.2MM, MICL 13.2, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS "TOO LONG". THE LENS WAS REMOVED AND SCHEDULED EXCHANGE OF A SHORTER LENGTH 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 Code Available

  MAUDE report 8631809 ↗
• MalfunctionFeb 26, 2019Contamination; Difficult to Fold, Unfold or Collapse; Contamination; Difficult to Fold, Unfold or Collapse

  THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) AND NOTED FOREIGN MATERIAL ON THE LENS. THE LENS WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372306 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) AND HIT THE CAPSULE WITH THE BLADE. THE LENS WAS REMOVED AND WAS NOT REPLACED. 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 8372261 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER STATED THAT A 13.2 MM MICL13.2, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED. 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 7789908 ↗
• MalfunctionJun 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON NOTICED THAT A 13.2 MM MICL13.2, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS TORN DURING INSERTION. THE LENS WAS REMOVED AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, AND NO SUTURE. THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7603593 ↗
• MalfunctionFeb 19, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTEDLY, WHILE PREPARING TO INSERT A 13.2MM MICL13.2, DIOPTER -16.0 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT (OS) EYE, THE LENS TORE. THIS WAS DISCOVERED AFTER THE LOADING PROCES. REPORTER STATES THEY ARE UNSURE AS TO WHETHER THE LENS WAS RECEIVED DAMAGED OR IF IT TORE DURING LOADING. THERE WAS NO PATIENT CONTACT WITH THIS LENS. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Patient Involvement

  MAUDE report 7281443 ↗
• InjuryDec 29, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTED INDICATED THAT THE SURGEON IMPLANTED A MICL13.2,-16.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS). ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, NARROWING OF THE ANGLE AND SHALLOWING OF ANTERIOR CHAMBER DEPTH (ACD). THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 7155836 ↗
• InjuryDec 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTED INDICATED THAT THE SURGEON IMPLANTED A MICL13.2,-16.0 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 VAULT, ELEVATED (INTRAOCULAR PRESSURE) IOP, NARROWING OF THE ANGLE AND SHALLOWING OF ANTERIOR CHAMBER DEPTH (ACD). THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. PATIENT POST-OP BCVA IS 20/40.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 7113646 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL13.2, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE REPORTER DID NOT KNOW IF THE CAUSE WAS DUE TO USER ERROR. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 6592833 ↗
• MalfunctionApr 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, WAS RETURNED DAMAGED. 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 6465439 ↗
• InjuryMar 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING. THE REPORTER INDICATED THAT THERE WAS NO PATIENT INJURY AND THE EVENT WAS NOT DEVICE RELATED BUT THE EXACT CAUSE WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6389631 ↗
• InjuryDec 20, 2016Device Operates Differently Than Expected; Activation Failure; Device Operates Differently Than Expected; Activation Failure

  THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, SEVERAL TIMES DURING THE SAME SURGERY DUE TO THE LENS WOULD NOT UNFOLD IN THE PATIENT'S EYE. THE LENS EVENTUALLY WAS TORN AND THE INCISION WAS ENLARGED TO REMOVE THE LENS. THE BACKUP LENS WAS IMPLANTED AND SUTURES WERE NOT REQUIRED. THERE WERE NO ADDITIONAL COMPLICATIONS AND THE PATIENT IS DOING WELL. THE REPORTER INDICATED THE SURGEON HAD PROBLEMS FOLDING THE LENS DURING THE LOADING PROCESS AND THE EVENT WAS DUE TO SURGEON/TECHNIQUE ERROR. THERE WERE NO ISSUES WITH THE LENS OR INJECTION SYSTEM.

  Patient problems: No Code Available

  MAUDE report 6191981 ↗
• MalfunctionDec 15, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE MANUFACTURER RECEIVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, FROM THE CUSTOMER DAMAGED. 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 6176021 ↗
• InjuryOct 12, 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, -16.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED DUE TO HIGH VAULTING AND ACUTE ANGLE CLOSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

  Patient problems: No Code Available

  MAUDE report 6024734 ↗
• MalfunctionSep 22, 2016Torn Material; Torn Material

  THE CUSTOMER RETURNED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, TO THE MANUFACTURER DAMAGED. THE CUSTOMER INDICATED THE HAPTIC RIPPED WHILE FOLDING. 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 5972062 ↗

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