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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.5) (REF VICM5 13.2)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -10.5; 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 sizing and focus problems such as too much space behind the lens, raised eye pressure, glare and incorrect correction, often needing the lens to be removed or exchanged. Of 23 reports naming its identifier, there were no deaths and 12 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
23
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00840311300945), received between Dec 1, 2022 and Mar 11, 2026 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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: 1 reportsFeb 2024: 1 reportsMar 2024: 1 reportsApr 2024: 2 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 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: 1 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

  • No Apparent Adverse Event11
  • Adverse Event Without Identified Device or Use Problem9
  • Off-Label Use3
  • Inadequacy of Device Shape and/or Size2
  • Misfocusing1
  • Patient Device Interaction Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Intraocular Pressure Increased2
  • Halo1
  • Visual Disturbances1

Recent adverse event reports

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

  • InjuryMar 11, 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 OVER/UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A TORIC LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN. 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.

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

    MAUDE report 24569789 ↗
  • InjuryJun 25, 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 AN EXCESSIVE VAULT AND PUPIL IMPAIRMENT. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND ON THE SAME DAY BUT DIFFERENT SURGERY THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS WITH A DIFFERENT POWER AND THE PROBLEM WAS MARKED AS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS OTHER, "ICL OVERSIZED, ON EXCHANGE THE VAULT HAS IMPROVED TO A 1CT, BUT SAME TEMPORAL IRIS SPHINCTER ATROPHY REMAINS." 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

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

    MAUDE report 22325474 ↗
  • 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 530 IN THE RIGHT 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 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; Halo; Intraocular Pressure Increased; Visual Disturbances

    MAUDE report 21551026 ↗
  • InjuryFeb 7, 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 IRIDO-CORNEAL ANGLES. THE LENS WAS LATER REMOVED AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. NORMAL ANTERIOR CHAMBER DEPTH RESTORED, AND INITIAL CROWDING OF IRIDO-CORNEAL ANGLES RESOLVED AFTER EXCHANGING ICL WITH A SMALLER SIZE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21334400 ↗
  • InjuryNov 22, 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 A REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR THE SAME SIZE DIFFERENT POWER. THE PROBLEM WAS RESOLVED. CAUSE 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20761819 ↗
  • InjurySep 18, 2024Adverse 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 HIGH VAULT AND INTRAOCULAR PRESSURE RISE. LENS REMAINS IMPLANTED. PER HEALTHCARE PROFESSIONAL VA EXCEEDS PRE-OP BCVA AND PATIENT IS HAPPY. 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: Intraocular Pressure Increased

    MAUDE report 20251620 ↗
  • InjuryJul 23, 2024Adverse 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 LOW VAULT. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE PROBLEM WAS NOT RESOLVED. FOLLOW-UP TREATMENT PLANNED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19805168 ↗
  • InjuryMay 1, 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, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2024 DUE TO EXCESSIVE VAULT. A SHORTER LENGTH LENS WAS IMPLANTED IN A SECOND SURGERY ON (B)(6) 2024. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS OTHER: WTW BETWEEN SIZES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19226719 ↗
  • MalfunctionApr 10, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS REMAINS IMPLANTED. REPORTEDLY, "THEY WILL NOT DO ANYTHING AND MONITOR THE CASE. LENS WILL NOT BE REMOVED." THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19081427 ↗
  • MalfunctionApr 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.50 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS REMAINS IMPLANTED. REPORTEDLY, "THEY WILL NOT DO ANYTHING AND MONITOR THE CASE. LENS WILL NOT BE REMOVED." THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19074222 ↗
  • MalfunctionMar 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024 AND THE PATIENT EXPERIENCED EXCESSIVE VAULT. IT WAS REPORTED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. REPORTER STATED THAT THE PATIENT IS HAPPY AND THE DOCTOR WILL MONITOR CLOSELY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18867245 ↗
  • MalfunctionFeb 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -10.5 DIOPTER LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FROM THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024, DUE TO A LENS TEAR/BREAK DURING LOADING AND THE LENS BEING STUCK IN CARTRIDGE OR INJECTION SYSTEM. THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY. CAUSE OF THE EVENT WAS THE DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18673920 ↗
  • MalfunctionJan 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2 -10.50 DIOPTER IMPLANTABLE COLLAMER LENS TORE/BROKE DURING LOADING. THERE WAS NO PATIENT CONTACT. A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18560168 ↗
  • MalfunctionNov 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. INTRAOPERATIVELY THE LENS WAS REMOVED WITH NO PATIENT INJURY. ON (B)(6) 2023 A REPLACEMENT LENS WAS OF THE SAME LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18188683 ↗
  • InjuryOct 3, 2023Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT ON (B)(6) 2023. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR, LENS TOO SHORT. REPORTEDLY, VAULT AND NEAR VISION IMPROVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17862045 ↗
  • MalfunctionSep 14, 2023Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -10.50 DIOPTER TORE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THERE WAS NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17750466 ↗
  • InjurySep 1, 2023Off-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 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17672650 ↗
  • InjuryMay 1, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. INTRAOPERATIVELY THE LENS AS REMOVED WITH NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16850167 ↗
  • MalfunctionApr 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT ON (B)(6) 2023 A 13.2MM, VICM5_13.2, -10.50 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE RIGHT EYE (OD). THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY. A REPLACEMENT LENS WAS IMPLANTED AT A LATER DATE AND THE PROBLEM RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16727226 ↗
  • MalfunctionMar 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS WAS TORN BEFORE LOADING. THE REPORTER INDICATED THE LENS WAS RECEIVED WITH A SMALL TEAR. AS THE LENS WAS BEING INJECTED INTO THE ANTERIOR CHAMBER, THE LENS CAME OUT FROM THE INJECTOR ALREADY BROKEN. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16595141 ↗
  • InjuryMar 10, 2023Off-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 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXCHANGED ON (B)(6) 2022 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT INDICATE THE CAUSE OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16519999 ↗
  • MalfunctionDec 9, 2022Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT HAS "WRONG REFRACTION" (OVER CORRECTION). LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR AND NOTED THE DEVICE FAILED TO PERFORM AS INTENDED; "WRONG INITIAL REFRACTION".

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

    MAUDE report 15955610 ↗
  • MalfunctionDec 1, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS; WHICH WAS INTENDED FOR THE PATIENT'S RIGHT EYE (OD); HAD TORE DURING LOADING. THIS OCCURRED ON (B)(6) 2022. THERE WAS NO PATIENT CONTACT. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15898870 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

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Sources and updates

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