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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0) (REF VICM5 13.2)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -11.0; Overall Diameter (Length): 13.2 · Class 3 · Implant

All models of EVO/EVO+VISIAN Implantable Collamer Lens (1030)

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

Quick summary

This STAAR EVO implantable lens is placed in the eye to correct vision. Reports mostly describe the lens sitting too high or not fitting well, often leading to removal and replacement with a shorter lens, with some mentions of blurred vision, glare and eye infection. There are 23 reports naming its identifier, with 19 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
23
Deaths reported
0
Injuries reported
19
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00840311300952), received between Mar 17, 2023 and Feb 5, 2026 — classified as 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 2 reportsJul 2024: 1 reportsAug 2024: 2 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem17
  • Inadequacy of Device Shape and/or Size3
  • No Apparent Adverse Event3
  • Misfocusing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
  • Blurred Vision2
  • Visual Disturbances2
  • Endophthalmitis1
  • Halo1
  • Hypopyon1
  • Intraocular Pressure Increased1

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED AN EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF ICA, SHALLOWING OF AC. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

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

    MAUDE report 24272624 ↗
  • InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2025. THE PATIENT EXPERIENCED ENDOPHTHALMITIS WHICH WAS NOTED ON (B)(6) 2025. PATIENT HAD A BILATERAL SEQUENTIAL SURGERY. CULTURES WERE PERFORMED AND RESULTS ARE UNKNOWN. TREATMENT WAS ALSO PERFORMED (MEDICATION). THE LENS WAS EXPLANTED BUT IT WAS NOTED THE PROBLEM IS NOT RESOLVED.

    Patient problems: Endophthalmitis; Hypopyon

    MAUDE report 24060621 ↗
  • InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS EXPLANTED AND REPLACED WITH THE SAME SIZE DIFFERENT POWER LENS AND THE PROBLEM RESOLVED. THE CAUSE OF EVENT WAS REPORTED AS UNKNOWN. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

    Patient problems: Blurred Vision

    MAUDE report 23687488 ↗
  • InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, AND ROTATION. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. KERATITIS WAS LATER NOTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

    MAUDE report 23518636 ↗
  • InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING, LENS ROTATION. THE LENS WAS REPOSITIONED BUT THE PROBLEM WAS NOT RESOLVED. THE LENS WAS THEN EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23362615 ↗
  • InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS AND PROBLEM WAS RESOLVED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY. CAUSE OF THE EVENT WAS REPORTED AS DEVICE/PATIENT-RELATED FACTOR/USER ERROR - LENS TOO LARGE FOR EYE.

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

    MAUDE report 22004905 ↗
  • InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED UNREACTIVE FIXED PUPIL, PIGMENT DISPERSION, GLARES/HALOES, ELEVATED IOP AND MEDICATION WAS PRESCRIBED. REPORTEDLY, "IT'S BEEN ABOUT THREE WEEKS NOW, BUT HER PUPIL IS STILL 5 TO 6 MM IN SIZE. HER EYE PRESSURE WAS SLIGHTLY RAISED , BUT WITH MEDICATION THEY ARE NOW 11 AND 12, THERE IS NO PUPIL IRREGULARITY. PENTACAM IMAGES SHOWED NO EVIDENCE OF IRIS OR PUPIL TUCK. PATIENT IS EXTREMELY UNHAPPY DUE TO GLARE AND HALOS, I HAVE STARTED THE PATIENT ON PILOCAR 2% EYE DROPS WITH AN ATTEMPT TO REDUCE THE PUPIL SIZE. THE SAME IS HAPPENING IN HER BOTH EYES . BOTH THE EYES VAULTING IS ABOUT 640 IN THE LEFT EYE ." IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

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

    MAUDE report 21551687 ↗
  • InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THAT THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20006342 ↗
  • InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THAT THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20002617 ↗
  • InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS REMAINS IMPLANTED.

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

    MAUDE report 19833936 ↗
  • InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_ 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.50 AS AN EXCHANGE LENS INTO THE PATIENT'S RIGHT EYE (OD) TO RESOLVE GLARE/HALOES AND LENS DISLOCATION/SUBLUXATION ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. REPORTEDLY, "ONE SIZE UP AND IT WAS FIXED, VERTICALLY, BUT AT THE TIME OF EXAMINATION THE DAY AFTER SURGERY, IT WAS ROTATED AND FIXED HORIZONTALLY AND STILL DEVIATED DOWNWARD. SO, THE LENS WAS REMOVED." THE CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR - "SUSPECTED CILIARY BAND FRAGILITY DUE TO TRAUMA."

    Patient problems: Visual Disturbances

    MAUDE report 19547747 ↗
  • MalfunctionJun 3, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.00 INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY "THE LENS BROKE" AND "THE LENSES HAVE BEEN EXPLANTED". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19449463 ↗
  • InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5 -11.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2024. INFORMATION ABOUT CONCOMITANT PRODUCTS USED INCLUDING OVD AND DELIVERY SYSTEM WERE NOT PROVIDED. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PER THE LAST REPORT DATED (B)(6) 2024, NO INFORMATION IS PROVIDED THAT THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO LOSS OF VISUAL ACUITY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: Toxic Anterior Segment Syndrome (TASS)

    MAUDE report 19281573 ↗
  • InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. PATIENT DISSATISFIED WITH VISUSAL ACCUITY. LENS EXCHANGED FOR A TOIC LENS ON (B)(6) 2023 AND PROBLEM RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18922745 ↗
  • InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. PATIENT DISSATISFIED WITH VISUSAL ACCUITY. LENS EXCHANGED FOR A TOIC LENS ON (B)(6) 2023 AND PROBLEM RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18922743 ↗
  • MalfunctionNov 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -11.0 DIOPTER TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENT'S LEFT EYE (OS) ON 20-SEP-2023. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED. A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS USER ERROR. REPORTEDLY, THE PATIENT IS "OK" AND THE STATUS OF THE EYE IS "QUIET."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18233716 ↗
  • InjuryOct 19, 2023Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0 DIOPTER WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO REFRACTIVE SUPRISE. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS OTHER.

    Patient problems: Blurred Vision

    MAUDE report 17971404 ↗
  • InjurySep 20, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT. REPORTEDLY, "PATIENT DOESN'T WANT TO HAVE AN EVO ICL IN ANOTHER LENGTH. SHE WERES CONTACT LENSES AGAIN."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17786422 ↗
  • MalfunctionAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0 DIOPTER TORE/BROKE BEFORE INJECTION INTO THE PATIENT'S RIGHT EYE (OD). THE PROBLEM WAS NOT RESOLVED. REPORTEDLY, "THE LENS BROKE INTO 3 PIECES INSIDE THE CARTRIDGE WITH NO REASON FOR THAT. IT WAS NOT IMPLANTED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17553146 ↗
  • MalfunctionAug 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -11.0 DIOPTER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS STUCK IN CARTRIDGE. THERE WAS NO PATIENT CONTACT AND NO PATIENT INJURY WAS REPORTED. A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED. REPORTEDLY, "LENS REPLACED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17461641 ↗
  • InjuryMay 12, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND LATER REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. PROBLEM RESOLVED. CAUSE OF EVENT WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16924380 ↗
  • InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -11 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. INTRAOPERATIVELY THE LENS WAS REMOVED DUE TO THE LENS WAS TORN. IT WAS NOTED THE LENS WAS DAMAGED DURING LOADING; AFTER OPENING THE VIAL; BUT DON'T REALLY KNOW WHEN THE LENS BROKE. IT WAS NOTED AN ADDITION OF NEW PI WAS ADDITIONALLY PERFORMED. A REPLACEMENT LENS WAS IMPLANTED AT A LATER DATE AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16827522 ↗
  • InjuryMar 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THIS EXCHANGE RESOLVED THE PROBLEM.

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

    MAUDE report 16562713 ↗

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-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-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-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.

Other Lens, Intraocular, Phakic devices

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Sources and updates

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