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Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103046)Recalls & reported problems

Staar Surgical Company · Diopter: -11.0; Overall Diameter (Length): 12.6 mm · Class 3 · Implant

All models of Visian ICL (Implantable Collamer Lens) (96)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This STAAR Visian ICL is an implantable lens placed in the eye to correct vision. Reports mostly describe fit problems where the lens sits too high, with increased eye pressure and narrowed drainage angles mentioned, often with removal and replacement with a shorter lens. There are 25 reports naming this identifier, with no deaths and 17 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
25
Deaths reported
0
Injuries reported
17
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00841542103046), received between Jan 19, 2017 and Apr 29, 2022 — classified as 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (10 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

Device problems

  • Inadequacy of Device Shape and/or Size10
  • Adverse Event Without Identified Device or Use Problem5
  • No Apparent Adverse Event5
  • Device Operates Differently Than Expected3
  • Misfocusing2
  • Off-Label Use2
  • Optical Problem2
  • Patient-Device Incompatibility2

Patient problems

  • Intraocular Pressure Increased10
  • No Code Available10
  • Blurred Vision5
  • No Clinical Signs, Symptoms or Conditions5
  • No Known Impact Or Consequence To Patient5
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • No Consequences Or Impact To Patient3
  • Inflammation2

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 29, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS -11.0 DIOPTER HAD "PATIENT CONTACT HOWEVER UNSURE WHAT HAPPENED." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. THE EVENT OCCURRED (B)(6) 2022.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14254370 ↗
  • InjuryApr 26, 2022Adverse 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; -11.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT EXPERIENCED ANGLE CLOSURE WITH ELEVATED INTRAOCULAR PRESSURE. ON (B)(6) 2022 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

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

    MAUDE report 14215325 ↗
  • InjuryFeb 2, 2022Inadequacy 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, -11.00 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING, PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE (IOP) AND ANGLE CLOSURE. THERE WAS ADDITION OF NEW PI AND ENLARGEMENT OF PI BY YAG ON (B)(6) 2021. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO LENS CALCULATOR ERROR.

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

    MAUDE report 13430229 ↗
  • InjuryJan 27, 2022Optical Problem; Optical Problem

    THE REPORTER INDICATED THAT A 12.6MM MICL12.6; -11.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). IT WAS INDICATED THAT THE LENS WAS TOO FLAT AND RESULTED IN MINIMAL CLEARANCE OVER THE NATURAL LENS, AND THERE WAS A SLIGHT CATARACT WITH A "SOMEWHAT" HYPEROPIC OUTCOME. THE LENS WAS EXPLANTED ON (B)(6) 2021. A REPLACEMENT LENS OF LONGER LENGTH AND DIFFERENT POWER WAS IMPLANTED AND THE PATIENT IS DOING QUITE WELL.

    Patient problems: Blurred Vision; Cataract

    MAUDE report 13374207 ↗
  • InjuryOct 20, 2021Inadequacy 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, -11.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE (IOP). AQUEOUS WAS RELEASED FROM THE CHAMBER. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

    MAUDE report 12669504 ↗
  • InjuryAug 4, 2021Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6; -11.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE PATIENT EXPERIENCED EXCESSIVE VAULTING; ELEVATED IOP; SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES; RETAINED VISCOELASTIC/OCUCOAT; AND ENLARGEMENT OF PI (SURGICAL) WAS PERFORMED ALONG WITH PARACENTESIS TO REDUCE IOP. ON (B)(6) 2021 THE LENS WAS EXPLANTED AND LATER THE SAME DAY REPLACED WITH A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED AND "PATIENT'S VAULT HAS SLOWLY DECREASED TO ACCEPTABLE LEVEL WITH DECREASING IOP". THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND NOTED "RETAINED VISCOELASTIC IN SMALL EYE & THICK BROWN IRIS".

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

    MAUDE report 12276620 ↗
  • InjuryAug 3, 2021Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6; -11.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE PATIENT EXPERIENCED EXCESSIVE VAULTING; ELEVATED IOP; SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES; RETAINED VISCOATELASTIC/OCUCOAT; AND ENLARGEMENT OF PI (SURGICAL) WAS PERFORMED ALONG WITH PARACENTESIS TO REDUCE IOP. ON (B)(6) 2021 THE LENS WAS EXPLANTED AND LATER THE SAME DAY REPLACED WITH A SHORTER LENGTH LENS. IT WAS NOTED POSTOPERATIVELY THE PATIENT HAD SHALLOW AC 1000MM VAULT BUT INDICATED THE PROBLEM WAS RESOLVED AND "PATIENT'S VAULT HAS SLOWLY DECREASED TO ACCEPTABLE LEVEL WITH DECREASING IOP". THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND NOTED "RETAINED VISELASTIC IN SMALL EYE & THICK BROWN IRIS".

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

    MAUDE report 12271376 ↗
  • InjuryMay 27, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

    THE REPORTER STATES A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS -11.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE UPSIDE DOWN ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED AND REPLACED WITH A BACK-UP LENS. NO PATIENT INJURY IS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11894541 ↗
  • MalfunctionFeb 18, 2021No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT ON (B)(6) 2021 A MICL 12.6, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE BEFORE/DURING LOADING. DAMAGE WAS NOTED WHILE LOADING. A BACKUP LENS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. PER THE REPORTER ON (B)(6) 2021, "PATIENT IS DOING FINE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11343199 ↗
  • MalfunctionOct 24, 2020No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS TORE DURING DELIVERY INTO THE PATIENTS RIGHT EYE (OD). THERE WAS NO PATIENT INJURY. ANOTHER SAME MODEL/LENGTH LENS WAS INSERTED DURING THE SAME SURGERY AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE AND USER ERROR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10731828 ↗
  • MalfunctionJul 29, 2020No Apparent Adverse Event; No Apparent Adverse Event

    RECEIVED A 12.6MM, MICL12.6,-11.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN CARTRIDGE. 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 10339263 ↗
  • InjuryMar 27, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON 26/FEB/2020. PUPIL BLOCK WITH ELEVATED IOP (48MMHG) AND ANGLE CLOSURE WITH ELEVATED IOP (48MMHG) WERE ASSESSED ON (B)(6) 2020, AND EXCESSIVE VAULT WAS OBSERVED. THE LENS WAS REMOVED AND REPLACED FOR A SHORTER LENGTH LENS ON (B)(6) 2020. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE (EXCESSIVE VAULT). REPORTEDLY, "PATIENT HAPPY."

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 9891527 ↗
  • InjuryFeb 28, 2020Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, - 11.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2019. THE PATIENT REPORTED EYE PAIN, WHICH WAS NOT RESOLVED WITH ARTIFICIAL TEARS OR WARM COMPRESSES. THE PATIENT GOT A SECOND OPINION BUT WAS UNABLE TO SOLVE THE SOURCE OF THE PAIN. THE PATIENT REQUESTED THE LENS BE REMOVED AND THE LENS WAS EXPLANTED ON (B)(6) 2020. THERE ARE NO PLANS TO IMPLANT ANOTHER ICL LENS. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT REPORTED POST-OP, HER EYE PRESSURE HAD INCREASED AND WAS TREATED WITH COMBIGAN. WAS ALSO TREATED FOR DRY EYE FOR OVER A MONTH. THE PATIENT'S CURRENT CONDITION IS STILL HAS OCCASIONAL PAIN, ESPECIALLY AT NIGHT.

    Patient problems: Dry Eye(s); Intraocular Pressure Increased; No Code Available; Pain

    MAUDE report 9772179 ↗
  • MalfunctionAug 8, 2019No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THE BACK HAPTIC OF A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, WAS NOTED TO BE TORN OFF PRIOR TO INJECTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8876513 ↗
  • InjuryApr 1, 2019Off-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 12.6MM MICL12.6, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS REMOVED AND REPLACED ON (B)(6) 2019 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ANGLE CLOSURE WITH ELEVATED IOP (65 MMHG). THIS RESOLVED THE PROBLEM.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 8471518 ↗
  • InjuryFeb 8, 2019Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO CHRONIC INFLAMMATION. THE INFLAMMATION WAS TREATED BUT IT WAS UNSUCCESSFUL AND THE LENS WAS EXPLANTED. THE PATIENT IS IMPROVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Patient problems: Blurred Vision; Inflammation; No Code Available

    MAUDE report 8322830 ↗
  • InjuryFeb 8, 2019Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO CHRONIC INFLAMMATION. THE INFLAMMATION WAS TREATED BUT WAS UNSUCCESSFUL AND THE LENS WAS EXPLANTED.. THE PATIENT IS IMPROVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Patient problems: Blurred Vision; Inflammation; No Code Available

    MAUDE report 8322791 ↗
  • MalfunctionJan 16, 2019Unintended Movement; Unintended Movement

    THE REPORTER INDICATED THE SURGEON INSERTED, REMOVED AND EXCHANGED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, WITHIN THE SAME SURGERY, DUE TO THE LENS FLIPPED WHEN IT WAS FULLY INSERTED. UPON REMOVAL OF THE LENS, THE LENS TORE. THERE WAS NO PATIENT INJURY. THE PROBLEM WAS RESOLVED WHEN THE LENS WAS EXCHANGED FOR THE BACKUP LENS. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8255277 ↗
  • InjuryJan 11, 2019Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM, MICL12.6, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018 AND EXCESSIVE VAULT WAS OBSERVED. THE LENS REMAINS IMPLANTED, SURGEON PLANNED TO EXCHANGED LENS ON (B)(6) 2019 BUT THE PATIENT RESCHEDULED SURGERY. ON (B)(6) 2019 IS THE EXPECTED DATE OF SURGERY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Halo; No Code Available; No Known Impact Or Consequence To Patient; Visual Disturbances

    MAUDE report 8241101 ↗
  • InjuryApr 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS HAD TO BE EXPLANTED BECAUSE THE "LENS WENT IN WRONG". A BACK-UP LENS WAS IMPLANTED. THERE WAS NO WIDENED INCISION AND NO SUTURES USED. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION HAVE NOT BEEN FORTHCOMING.

    Patient problems: No Code Available

    MAUDE report 7398184 ↗
  • InjuryJan 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGERY IMPLANTED A MICL12.6, -11.0 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 THE LENS BEING TOO BIG. THE LENS WAS EXCHANGED FOR SHORTER LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 7197904 ↗
  • MalfunctionJan 5, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER INDICATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, WAS IMPLANTED AND REFRACTIVE SURPRISE WAS OBSERVED AFTER SURGERY. THE REPORTED STATED THAT TIME CORRECTED THE PROBLEM AND THAT THE LENS REMAINS IMPLANTED. LENS REMOVAL WAS NOT NECESSARY, PATIENT IS DOING GREAT AND IS VERY HAPPY.

    Patient problems: Blurred Vision; No Consequences Or Impact To Patient

    MAUDE report 7169824 ↗
  • InjuryJul 20, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6 MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENTS EYE ON (B)(6) 2017. THE LENS WILL BE EXPLANTED FOR A SHORTER 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 Code Available; No Known Impact Or Consequence To Patient

    MAUDE report 6727761 ↗
  • InjuryFeb 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXTREME VAULTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

    MAUDE report 6324404 ↗
  • MalfunctionJan 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER STATED THE HAPTIC OF A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, WAS TORN WHILE BEING LOADED AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6265501 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-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-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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