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Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103305)Recalls & reported problems

Staar Surgical Company · Diopter: -10.5; Overall Diameter (Length): 13.2 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 SURGICAL Visian ICL implantable collamer lens is a corrective eye lens placed inside the eye to reduce nearsightedness. The 31 reports mostly describe sizing and fit problems — lenses that sit too high or too low, sit off-center, shift or dislocate, or will not unfold properly during surgery — along with glare and halos after implantation and, in some cases, pressure rising inside the eye. No deaths were reported; 23 injuries and 8 malfunctions were. There are no recalls naming this lens.

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
31
Deaths reported
0
Injuries reported
23
Recalls naming it
0

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00841542103305), received between Mar 22, 2016 and Feb 8, 2024 — classified as 23 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (19 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size19
  • Adverse Event Without Identified Device or Use Problem4
  • Device Operates Differently Than Expected4
  • Unintended Movement3
  • Optical Problem2
  • Activation, Positioning or Separation Problem1
  • Misfocusing1
  • No Apparent Adverse Event1

Patient problems

  • No Code Available17
  • Intraocular Pressure Increased8
  • No Clinical Signs, Symptoms or Conditions5
  • No Known Impact Or Consequence To Patient3
  • No Patient Involvement3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Blurred Vision2
  • Halo2

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Optical Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Optical Problem; Unintended Movement

    THE REPORTER INDICATED THAT 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS OF A -10.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2024, THE LENS WAS REMOVED AND A LONGER LENGTH LENS WAS IMPLANTED DUE TO LENS DISLOCATION/SUBLUXATION, GLARE/HALOES, AND DECENTRATION OF LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. STATUS OF THE EYE IS REPORTED AS "HEALTHY."

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

    MAUDE report 18673586 ↗
  • MalfunctionMar 24, 2022Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS OF -10.5 DIOPTER WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. REFRACTIVE SURPRISE WAS OBSERVED. THE LENS REMAINS IMPLANTED. CAUSE REPORTED AS DEVICE FAILED TO PERFORM AS INTENDED DUE TO "ORDERED TOO HIGH POWER ICL."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13894304 ↗
  • InjuryNov 18, 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, -10.5 DIOPTER INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM IS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12840508 ↗
  • InjuryNov 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A 13.2MM, MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE EYE. "COULD NOT FIND POSITION FOR LENS" WAS REPORTED. THERE WAS NO PATIENT INJURY. BACKUP LENS WAS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12808259 ↗
  • MalfunctionSep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) 2 TIMES, DURING THE SAME SURGERY DUE TO THE LENS WOULD NOT UNFOLD. THERE WAS SOME IRIS PROLAPSE DURING THE PROCEDURE. AFTER THE SECOND TRY, THE SURGEON REPLACED THE LENS WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. POST-OP, THE VAULT IS NORMAL AND SOME CORNEAL EDEMA. CONTINUE VIGAMOX/ACULAR/PF QID OU. THE LENS WAS DISCARDED.

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

    MAUDE report 12478420 ↗
  • InjurySep 1, 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, -10.50 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS OTHER, "PATIENT WAS HAPPY WITH VISION BUT SURGEON RECOMMENDED A LENS EXCHANGE DUE TO A HIGH VAULT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12406975 ↗
  • InjuryFeb 17, 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, -10.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE. THE SURGEON REPORTS 3+ VAULT; THE LENS WAS REPOSITIONED AND THE WOUND WAS BURPED. REPORTEDLY THE PATIENT IS DOING WELL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11340673 ↗
  • InjuryJan 30, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Unintended Movement

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2012. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR THE SAME MODEL LENS, LENGTH AND DIOPTER DUE TO LOW VAULT OVERTIME, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, PARTIAL ANGLE CLOSURE (FOCAL ANGLE CLOSURE) AND PROGRESSIVE NARROWING OF ANGLE WITH ELEVATED IOP (THAT REQUIRED MEDICAL INTERVENTION). THIS EXCHANGE RESOLVED THE PROBLEM. THE CAUSE OF THIS EVENT WAS DUE TO THE LENS BEING IMPLANTED UPSIDE DOWN. THE REPORTER STATED " THE ORIGINAL ICL WAS INADVERTENTLY INVERTED ON INSERTION. THIS WAS NOT RECOGNIZED UNTIL SEVERAL YEARS AFTER SURGERY, SINCE THE PATIENT HAD GOOD VISION AND WAS TEMPORARILY LOST TO FOLLOW UP. SHE WAS REFERRED BACK TO ME INTERNALLY FROM A COLLEAGUE WHO NOTED FOCAL ANGLE CLOSURE IN ONE EYE ONLY AND INCREASING IOP. UBM REVEALED AN INVERTED ICL IN THAT EYE, WHICH I EXCHANGED SUCCESSFULLY. I BELIEVE THAT THE SMALLER INCISION BUTTERFLY STYLE INJECTOR I WAS USING AT THE TIME FOR SEVERAL MONTHS (ON ADVICE OF THE LOCAL REP AT THAT TIME) CONTRIBUTED TO THE INVERSION OF THE ICL."

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 9648851 ↗
  • InjuryAug 7, 2019Unintended Movement; Unintended Movement

    A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2019. REPORTEDLY, THE LENS FLIPPED DURING INSERTION. IT WAS REMOVED AND REPLACED WITH ANOTHER ICL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Patient problems: No Code Available

    MAUDE report 8870926 ↗
  • InjuryJun 14, 2019Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND ELEVATED IOP (21MMHG) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE, EXCESSIVE VAULT WAS OBSERVED. PHACO-EMULSIFICATION (CATARACT SURGERY) AND IOL IMPLANTATION WAS DONE, THE LENS WAS REMOVED ON (B)(6) 2019. CAUSE OF THE EVENT IS REPORTED AS DEVICE, "ICL TOO LARGE".

    Patient problems: Intraocular Pressure Increased

    MAUDE report 8699719 ↗
  • InjuryApr 18, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT, PUPIL BLOCK WITH IOP (INTRAOCULAR PRESSURE), ANGLE CLOSURE, CORNEAL DECOMPENSATION, LENS DISLOCATION/SUBLUXATION, AND UNREACTIVE (FIXED) PUPIL. A REPLACEMENT LENS OF SHORTER LENGTH WAS LATER IMPLANTED. SURGEON IS NOT SURE YET IF THE EXCHANGE LENS RESOLVED THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS CASE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Corneal Decompensation; Intraocular Pressure Increased; No Code Available

    MAUDE report 8529658 ↗
  • InjuryApr 10, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -10.50 WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT AND PUPIL BLOCK WITH ELEVATED IOP (INTRAOCULAR PRESSURE). ADDITIONAL SURGICAL INTERVENTION (ENLARGEMENT OF PI OR ADDITION OF NEW PI/ YAG) WAS REPORTED TO BE PERFORMED. ON (B)(6) 2019 THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 8500521 ↗
  • InjuryFeb 19, 2019Inadequacy 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, -10.5 DIOPTER, INTO THE PATIENT'S EYE ON (B)(6) 2019. ON THE SAME DATE, IN A SEPARATE SURGERY, THE SURGEON EXCHANGED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. PATIENT IS "DOING WELL" AFTER THE EXCHANGE.

    Patient problems: No Code Available

    MAUDE report 8350782 ↗
  • MalfunctionJan 2, 2019No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT AS THE SURGEON WAS LOADING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, IT TORE. THIS OCCURRED ON 11-OCT-2018. THIS WAS REPORTEDLY DUE TO A LOADING ERROR. THERE WAS NO PATIENT CONTACT AND A BACK-UP LENS WAS USED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Patient problems: No Patient Involvement

    MAUDE report 8208778 ↗
  • InjuryDec 10, 2018Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

    THE REPORTER INDICATED THAT ON (B)(6)2018 THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE. ON (B)(6)2018 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT AND GLARE/HALOS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS USER ERROR, STATING "THE IMPLANT PLACED WAS TOO BIG."

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

    MAUDE report 8149320 ↗
  • InjuryNov 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -10.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ANGLE CLOSURE WITH ELEVATED IOP. THIS EXCHANGE RESOLVED THE PROBLEM.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 8068768 ↗
  • InjuryJun 8, 2018Inadequacy 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, -10.5 DIOPTER , IMPLANTABLE COLLAMER LENS AND RESULTED IN A VERY HIGH VAULT , ANGLE CLOSURE WITH ELEVATED IOP (INTRAOCULAR PRESSURE) WAS ALSO OBSERVED. THE LENS 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 REPORT WILL BE SUBMITTED.

    Patient problems: Intraocular Pressure Increased; No Code Available; Patient Problem/Medical Problem

    MAUDE report 7583196 ↗
  • InjuryApr 27, 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, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS REMOVED ON (B)(6) 2018 DUE TO OBSERVATION OF EXCESSIVE VAULT WITH GLARE/HALOES AND BLURRED VISION. IT WAS REPORTED THAT THE LENS WAS REPOSITIONED BUT IT DID NOT RESOLVE THE PROBLEM. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

    Patient problems: No Code Available

    MAUDE report 7470285 ↗
  • MalfunctionApr 20, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER INDICATED THAT A 13.2MM MICL13.2, 10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WOULD NOT FOLD IN THE CARTRIDGE CORRECTLY WHEN LOADING. NO PATIENT CONTACT. BACK UP 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 Patient Involvement

    MAUDE report 7449090 ↗
  • InjuryApr 19, 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, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR SHORTER LENS DUE TO OBSERVATION OF EXCESSIVE VAULT WITH RECURRENT ANGLE CLOSURE/GLAUCOMA (X4). ACCORDING TO REPORTER ADDITIONAL SURGICAL INTERVENTIONS (ENLARGEMENT OF PI AND ADDITION OF NEW PI) WERE PERFORMED. THE REPLACEMENT LENS OF SHORTER LENGTH RESOLVED THE PROBLEM.

    Patient problems: No Code Available

    MAUDE report 7444101 ↗
  • MalfunctionMar 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTED INDICATED THAT A 13.2MM MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACK UP LENS WAS USED. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

    Patient problems: No Patient Involvement

    MAUDE report 7339633 ↗
  • MalfunctionFeb 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER INDICATED THAT THE THE SURGEON ATTEMPTED TO LOAD A 13.2 MM MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS ON (B)(6) 2018, BUT IT WAS LOADED INCORRECTLY. THERE WAS NOT ANYTHING UNUSUAL THAT LED TO THE PROBLEM. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7268462 ↗
  • InjuryDec 7, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, ELEVATED IOP, ANGLE CLOSURE, NARROWING OF THE ANGLE, SHALLOWING OF THE ACD, BLURRY VISION, PAIN AND CORNEAL EDEMA. PARACENTESIS WAS DONE TO LOWER THE PRESSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. ON (B)(6) 2017, THE PATIENT'S POST-OP BCVA WAS 20/25.

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

    MAUDE report 7097942 ↗
  • InjuryAug 30, 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, -10.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE REPORTER STATED THE PATIENT WAS IN PAIN AND HAD ELEVATED INTRAOCULAR PRESSURE (PRESSURE SPIKE). THE PERIPHERAL IRIDOTOMIES WERE CLOSED, WITH A SHALLOW CHAMBER AND ANGLE CLOSURE. THE SURGEON DECIDED TO EXPLANT THE LENS THE SAME DAY. A THIRD LENS WAS NOT IMPLANTED. THE LENS WAS DISCARDED. THE PATIENT IS DOING FINE. THIS LENS WAS THE EXCHANGE LENS FOR A LONGER LENS IMPLANTED - SEE MDR #2023826-2017-01382.

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

    MAUDE report 6832461 ↗
  • InjuryAug 24, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGEON IMPLANT A MICL13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

    Patient problems: No Code Available

    MAUDE report 6818721 ↗

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-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-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-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.

Other Lens, Intraocular, Phakic devices

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Sources and updates

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