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Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103343)Recalls & reported problems

Staar Surgical Company · Diopter: -12.5; 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 Visian ICL is an implantable lens placed inside the eye to correct vision. The 26 reports mostly describe lenses that were the wrong size, causing raised eye pressure and blurred vision, plus a few that tore while being prepared for implanting. The reports note 17 injuries and no deaths. 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
26
Deaths reported
0
Injuries reported
17
Recalls naming it
0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00841542103343), received between Jan 13, 2016 and Sep 14, 2022 — classified as 17 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (15 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 Size15
  • Device Operates Differently Than Expected4
  • No Apparent Adverse Event4
  • Appropriate Device Problem Term/Code Not Available2
  • Insufficient Device Problem Information2
  • Optical Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Device Dislodged or Dislocated1

Patient problems

  • No Code Available12
  • Intraocular Pressure Increased9
  • Visual Disturbances6
  • Blurred Vision5
  • Halo4
  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient4
  • No Known Impact Or Consequence To Patient4

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

  • InjurySep 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS OF -12.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE(OS) ON (B)(6) 2022. PUPIL BLOCK WITH ELEVATED IOP; ANGLE CLOSURE WITH ELEVATED IOP WAS OBSERVED. ON (B)(6) 2022 THE LENS WAS EXPLANTED AND AT A LATER DATE A REPLACEMENT LENS OF A DIFFERENT MODEL BUT SAME SIZE AND DIOPTER WAS IMPLANTED. THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS DEVICE.

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

    MAUDE report 15423694 ↗
  • InjuryMay 25, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM MICL13.2 -12.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT EXPERIENCED EXCESSIVE VAULT, PUPIL BLOCK, ANGLE CLOSURE, ELEVATED INTRAOCULAR PRESSURE, UNREACTIVE (FIXED) PUPIL, AND BLURRED VISION. ADDITIONAL MEDICAL INTERVENTION (AQUEOUS SUPPRESSANTS AND DIOMOX) WERE PRESCRIBED. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH, SAME MODEL AND POWER LENS. IT WAS REPORTER THAT THE EXCHANGE RESOLVED THE PROBLEM. HOWEVER, IT WAS ALSO REPORTED THAT THE VAULT IS STILL HIGH. FOR STATUS OF THE EYE THE REPORTER STATED " QUIET, COMFORTABLE, STABLE, HAPPY PATIENT." IN THE REPORTERS OPINION THE DEVICE AND PATIENT-RELATED FACTOR WAS THE CAUSE OF THIS EVENT.

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

    MAUDE report 14493426 ↗
  • InjuryMay 19, 2022Inadequacy 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, -12.5 DIOPTER INTO THE PATIENT'S EYE ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED DUE TO THE LENS BEING TOO LARGE. REPORTEDLY THE LENS WAS REPLACED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14439552 ↗
  • MalfunctionApr 27, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE 13.2 MICL13.2 OF -12.5 DIOPTER HAPTIC TORE DURING LOADING INTO THE CARTRIDGE. NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14220792 ↗
  • MalfunctionJul 14, 2021No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM, MICL 13.2, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE LENS TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN, LENS BEGAN TO TWIST AND WOULD NOT UNFOLD, BUT ON ITS SIDE. SURGEON TRIED TO FLIP LENS BUT COULD NOT. SURGEON REMOVED LENS AND LENS TORE. REPORTEDLY, MILD EDEMA TO INFERIO-TEMPORAL CORNEA WAS DUE TO REMOVAL AND REPLACEMENT. NO OUTSIDE POSTOPERATIVE CARE. 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 12167115 ↗
  • InjuryFeb 10, 2021Inadequacy 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 13.2MM MICL13.2, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXCHANGED WITH A FOR A SHORTER LENGTH LENS DUE TO ELEVATED IOP (28MMHG) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE (ASSESED ON (B)(6) 2020), PIGMENT DISPERSION, UNREACTIVE(FIXED) PUPIL, GLARE/HALOES, IRIS ATROPHY, AND EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS "EXCESSIVE VAULT CAUSING PIGMENTARY DISPERSION AND INCREASED EYE PRESSURE." REPORTEDLY, "VAULT IS NOW BETTER, ALONG WITH IOP.

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

    MAUDE report 11308925 ↗
  • InjuryOct 29, 2020Inadequacy 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, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. EXCESSIVE VAULT WAS OBSERVED. 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10755780 ↗
  • MalfunctionApr 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE DOCTOR FELT THAT A 13.2MM, MICL 13.2, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS NOT LOADED CORRECTLY. LENS DID NOT FEEL RIGHT INJECTING INTO THE EYE. HE THOUGHT THAT MAYBE THERE WAS DAMAGE TO THE LENS AND DID NOT WANT TO USE IT AND IMPLANTED THE BACKUP LENS. THE LENS MADE CONTACT WITH THE PATIENTS EYE BUT THERE WAS NO PATIENT INJURY. THE DOCTOR FEELS IT WAS A LOADER ERROR.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9913408 ↗
  • InjuryJan 27, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, GLARE/HALOES AND BLURRED VISION. PRK, REFRACTIVE TREATMENT WAS ALSO REPORTED AS A SECONDARY INTERVENTION. IT WAS REPORTED THAT THE EXCHANGE LENS RESOLVED THE PROBLEM. AT PATIENTS POST OP FOLLOW UP VISIT " SOME GLARE AT NIGHT " AND " S/P PRK DOING BETTER, MUCH BETTER VAULT" WAS NOTED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS ICL (HIGH VAULT CAUSING SECONDARY ABERRATIONS, REFRACTORY TO CONTACT LENS CORRECTION).

    Patient problems: Blurred Vision; Halo; No Code Available; Visual Disturbances

    MAUDE report 9634216 ↗
  • MalfunctionMar 25, 2019Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM, MICL13.2, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO PATIENT'S EYE ON (B)(6) 2019. REPORTEDLY THE SURGEON "WILL DETERMINE IF THE LENS NEEDS TO BE EXCHANGED DUE TO VAULT". LENS REMAINS IMPLANTED. "THERE ARE NO COMPLICATIONS WITH PATIENT AS OF NOW." 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 8447842 ↗
  • MalfunctionMar 20, 2019Unintended Movement; Unintended Movement

    THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, AND NOTED THE LENS WENT INTO THE PATIENTS EYE UPSIDE DOWN. THE LENS WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8438526 ↗
  • InjuryAug 30, 2018Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT A 13.2MM MICL13.2 , -125 DIOPTER WAS IMPLANTED AND REMOVED ON (B)(6) 2018 DUE TO HIGH IOP AND UNHAPPY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Patient problems: Intraocular Pressure Increased; No Code Available; Visual Disturbances

    MAUDE report 7835113 ↗
  • InjuryAug 10, 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, -12.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) 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 7773025 ↗
  • InjuryJun 22, 2018Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFTT EYE (OS) 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, ANGLE CLOSURE, PIGMENT DISPERSION, UNREACTIVE (FIXED) PUPIL, GLARE/HALOES, AND IRIS ATROPHY. ADDITIONAL SURGICAL INTERVENTION (ENLARGEMENT, ADDITION OF NEW PI AND REPOSITIONING) WERE PERFORMED. IT WAS REPORTED THAT AT PATIENTS LAST FOLLOW UP ((B)(6) 2018) THE PATIENT WAS ON FOUR DIFFERENT GLAUCOMA DROPS, IOP 25MMHG. ADDITIONAL INFORMATION REPORTED, PI PATENT, PATIENT REPORTS DECREASED GLARE. EXPLANTED ICL AFTER ROTATION, IRIS CELL AND FLARE INCREASED THE IOP.

    Patient problems: Halo; Intraocular Pressure Increased; Iritis; No Code Available; Visual Disturbances

    MAUDE report 7631046 ↗
  • MalfunctionMay 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -12.5 DIOPTER TORE DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BACK UP LENS WAS USED WITH NO PROBLEM. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

    Patient problems: No Patient Involvement

    MAUDE report 7520478 ↗
  • InjuryMay 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -12.50, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED DUE TO OBSERVATION OF EXCESSIVE VAULT, ELEVATED INTRAOCULAR PRESSURE WITHOUT PUPIL BLOCK AND ANGLE CLOSURE (DATE ASSESSED: (B)(6) 2018), UNREACTIVE (FIXED) PUPIL, GLARE/HALOES, AND BLURRED VISION. ADDITIONAL SURGICAL INTERVENTION ( ENLARGEMENT OF PI; YAG) AND MEDICAL INTERVENTION (INTRAOCULAR INJECTION) WERE PERFORMED/PRESCRIBED. THE REPORTED STATED THAT THE CAUSE OF THIS EVENT WAS UNKNOWN. "FIXED PUPIL" WAS REPORTED FOR STATUS OF THE EYE AT PATIENT'S LAST FOLLOW UP. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

    MAUDE report 7480272 ↗
  • InjuryMar 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE REPORTER INDICATED THE LENS WAS TO BE EXPLANTED AND 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; No Known Impact Or Consequence To Patient

    MAUDE report 7327005 ↗
  • InjuryMar 9, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE REPORTER INDICATED THE LENS WAS TO BE EXPLANTED AND 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; No Known Impact Or Consequence To Patient

    MAUDE report 7326990 ↗
  • InjuryMar 1, 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, -12.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO EXCESSIVE VAULTING AND WAS EXCHANGED FOR A SHORTER LENS. THE LENS WAS DISCARDED. 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; No Code Available

    MAUDE report 7308043 ↗
  • InjuryAug 4, 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, -12.5 DIOPTER. IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS HAD A HIGH VAULT AND DUE TO CONCERNS OVER ANGLE CLOSURE, THE LENS WAS EXPLANTED ON (B)(6) 2017. THE PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE AND NARROWING OF THE ANGLE. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S CURRENT CONDITION WAS 20/20 UCVA, WITH GREAT INTRAOCULAR PRESSURE. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 6767795 ↗
  • InjuryJun 21, 2017Inadequacy 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, -12.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE, PUPILLARY BLOCK, NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE PATIENT EXPERIENCED BLURRY VISION AND CORNEAL EDEMA. THE REPORTER INDICATED MULTIPLE PARACENTISIS PERFORMED AND THE PERIPHERAL IRIDECTOMIES WERE REDONE. THE PATIENT WAS PRESCRIBED MEDICATION. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE PATIENTS POST-OP CONDITION IS - TRACE K EDEMA, 1+ CELLS WITH SHALLOW ANTERIOR CHAMBER, DILATED PUPIL WITH CORNEAL IRIS TOUCH PERIPHERALLY, AND BEST-CORRECTED VISUAL ACUITY 20/200. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

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

    MAUDE report 6658366 ↗
  • InjuryApr 6, 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, -12.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING. THE PATIENT EXPERIENCED BLURRED VISION AND PAIN. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

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

    MAUDE report 6468284 ↗
  • MalfunctionMar 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE CUSTOMER RETURNED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, 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 6426153 ↗
  • MalfunctionMar 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER STATED THAT A MICL13.2 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, TORE DURING LOADING. THERE WAS PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED IT WAS NOT DUE TO USER ERROR. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6393828 ↗
  • InjuryJun 27, 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 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016 AND NOTED AN EXCESSIVE VAULT IMMEDIATELY AFTER THE SURGERY. THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, NARROWING OF THE ANGLE, AND SHALLOWING OF THE ACD ON THE SAME DAY WHEN THE PATIENT CAME BACK TO THE FACILITY. THE LENS WAS EXCHANGED FOR A 12.6MM ICL AND THE ADDITIONAL PERIPHERAL IRIDECTOMY (PI) WAS PERFORMED. THE REPORTER INDICATED THAT THE CAUSE OF THE EVENT WAS NOT PRODUCT-RELATED.

    Patient problems: No Code Available

    MAUDE report 5751220 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • 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-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-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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