EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00840311300891), received between Oct 11, 2022 and May 19, 2026 — classified as 22 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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

Recent adverse event reports

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

• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED NARROW ANGLES. THE LENS WAS EXCHANGED FOR A SAME MODEL, POWER BUT SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. 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 25218966 ↗
• InjuryDec 22, 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 ENDOPHTHALMITIS. IT IS REPORTED THAT THE PATIENT IS CURRENTLY IMPROVING. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Glaucoma; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 23867283 ↗
• InjuryDec 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 A LENS ROTATED. IN A SEPARATE VISIT THE LENS WAS REPOSITIONED. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Halo; No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 23790524 ↗
• InjuryJul 21, 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 EXCESSIVE VAULT AND ELEVATED IOP WITHOUT PUPIL BLOCK AND ANGLE CLOSURE. DUE TO EXCESSIVE VAULT AND ELEVATED IOP WITHOUT PUPIL BLOCK AND ANGLE CLOSURE, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

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

  MAUDE report 22561853 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A REPLACEMENT IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HIGH VAULT AND CATARACT. CAUSE OF THE EVENT WAS REPORTED AS 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. 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: Cataract

  MAUDE report 21962861 ↗
• InjuryApr 30, 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 AN EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER. CAUSE DETAILS PROVIDED: "SIZE PROBLEM WE NEED NEW SIZE BETWEEN 13.2 AND 12.6".

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

  MAUDE report 21936085 ↗
• InjuryMar 17, 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, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND HEADACHES. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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: Headache

  MAUDE report 21627503 ↗
• InjuryJan 17, 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 ON (B)(6) 2024, AS A REPLACEMENT LENS TO A PRIOR TASS AND ENDOPHTHALMITIS. IT WAS NOTED "TASS OCCURRED AFTER OPERATIVE, BUT SINCE (B)(6) WAS CLOSED, THE LENS WAS REMOVED AT (B)(6). TO AVOID SUCH SITUATION, IT IS REQUESTED THAT THE COMPANY TAKES ACTION TO ADDRESS THE CAUSES AND COUNTERMEASURES AND SHOWS ITS STANCE". IT WAS INDICATED THE PROBLEM WAS NOT RESOLVED DUE TO THE PATIENT STILL BEING UNDER OBSERVATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21185729 ↗
• InjuryJan 15, 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 ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE MSI DELIVERY SYSTEM WITH SFC-45 WITH FTP AND OPEGAN OVD. TREATMENT AND DIAGNOSTICS WERE NOT PERFORMED. THE LENS WAS EXPLANTED AND LATER REPLACED WITH A SAME LENGTH AND POWER LENS BUT THE PROBLEM WAS NOT RESOLVED. IT IS NOTED THE WITH THE INITIAL LENS THAT THE PATIENT IS UNDER OBSERVATION, TASS OCCURRED AFTER OPERATION. THE LENS WAS REMOVED AT A DIFFERENT CLINIC.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21164185 ↗
• InjuryDec 9, 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 REFRACTIVE SURPRISE. LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS. PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880041 ↗
• InjuryDec 4, 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 -8.00D INTO A LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE: MSI-PF, SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER, OPEGAN OVD AND COAXIAL I/A HANDPIECE FOR ITS REMOVAL FOR 120 SEC. TASS WAS DIAGNOSED BILATERALLY. THE OS WAS DESCRIBED WITH SEVERE INFLAMMATION CELL+++, MILD CILIARY HYPEREMIA, MODERATE FIBRIN ON THE PUPIL AREA AND PATIENT EXPERIENCE OF BLURRED VISION. FREQUENT STEROID DROPS AND ORAL STEROIDS WERE PRESCRIBED ALONG WITH AC LAVAGE. ON UNKNOWN DATE THE ICL WAS EXPLANTED. BY DAY 9 THE ISSUE WAS REPORTED AS RESOLVED WITH BCVA 20/17 (SAME AS PRE-OP) AND IOP 17MMHG. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20849701 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO A RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE: ACCUJECT UNIFIT INJECTOR, SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER, OVD (OPEGAN, OPEGAN HI) AND COAXIAL I/A HANDPIECE FOR ITS REMOVAL FOR 60 SEC. TASS WAS DIAGNOSED ON DAY 1 DESCRIBED AS MODERATE INFLAMMATION WITH CELL++, HYPEREMIA, MILD FIBRIN COVERING PART OF PUPIL, MODERATE DEPOSITION (UNSPECIFIED) ON THE LENS SURFACE AND PATIENT EXPERIENCE OF BLURRED VISION. FREQUENT STEROID DROPS AND ORAL STEROIDS WERE PRESCRIBED. ON DAY 2 THE ISSUE WAS REPORTED AS RESOLVED WITH BCVA 20/13 AND IOP 1MMHG. THE LENS REMAINS IMPLANTED. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.

  Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20825744 ↗
• InjuryNov 7, 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 AN ANTERIOR SUBCAPSULAR CATARACT (ASC). IN A SEPARATE VISIT THE LENS WAS EXPLANTED. REPORTEDLY, "SURGEON PLAN TO DO PHACO AND IOL IMPLANTATION AFTER THE EYE CONDITION IS STABLE". ADDITIONAL INFORMATION PROVIDED, "DURING ICL EXPLANTATION, THERE WERE POSTERIOR SYNECHIAE AND FIBRIN. I REMOVED THE POSTERIOR SYNECHIAE ON THE ICL USING AN IRIS SPATULA, THE FIBRIN WAS TAKEN WITH ULTRATA. DURING INSTALLATION, IT LOOKS LIKE THE VISCO EVACUATION HAS BEEN CONFIRMED TO BE CLEAN." THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. CAUSE DETAILS PROVIDED: "CRYSTALLINE LENS CLOUDINESS AT D+2 AFTER ICL IMPLANTATION". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Cataract; Intraocular Pressure Increased

  MAUDE report 20635237 ↗
• InjuryJul 8, 2024Adverse 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 -8.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024, THE LENS WAS REMOVED. REPORTEDLY, "SUSPICION OF THE PRESENCE OF A FUNGUS GROWING ON THE LENS SURFACE." NETDEX COL EVERY 3 HOURS WAS PROVIDED. THE EYE IS QUIET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697765 ↗
• MalfunctionMay 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5 13.2, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2024. EXCESSIVE VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308611 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.00 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REMOVED ON (B)(6) 2024 DUE TO EXCESSIVE VAULTING AND REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265038 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5 -8.00D IMPLANTABLE COLLAMER LENS WAS IMPLANTED BY THE SURGEON INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. CONCOMITANT OVD AND DELIVERY SYSTEM INFORMATION WAS NOT PROVIDED. DAY 1 ONSET OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS NOTED. DIAGNOSTIC CULTURES WERE NOT PERFORMED. ANTIBIOTIC AND STEROID OPHTHALMIC DROPS WERE PRESCRIBED. THE CAUSE OF THE EVENT WAS THOUGHT TO BE CONTAMINATION OR RESIDUE IN THE LENS VIAL OR INJECTOR. SUBJECTIVE SYMPTOMS IMPROVED WITH THE LAST VISUAL ACUITY NOTED AS OF (B)(6) 2024 TO BE 1.0 (20/20). THE REPORTER NOTES CRYSTALLINE LENS CLOUDING. THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19075268 ↗
• MalfunctionApr 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -8.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. INTRAOPERATIVELY THE LENS WAS REMOVED DUE TO LOW VAULT AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068586 ↗
• InjuryFeb 9, 2024Inadequacy of Device Shape and/or Size; 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 -8.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682152 ↗
• MalfunctionJan 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A 8.0 DIOPTER WAS INTRAOPERATIVELY IMPLANTED AND REMOVED FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540560 ↗
• InjuryNov 22, 2023Inadequacy of Device Shape and/or Size; 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 -8.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT. THAT SAME DAY A SHORTER LENGTH LENS WAS IMPLANTED HOWEVER IT IS UNCLEAR IF THIS WAS PERFORMED INTRAOPERATIVELY. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196743 ↗
• InjuryNov 20, 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 -8.0 DIOPTER INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED WITH SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, ELEVATED IOP AND ANGLE CLOSURE AFTER SURGERY. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 18176646 ↗
• MalfunctionOct 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -8.00 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 INJURY. ON THIS SAME DATE A REPLACEMENT LENS WAS IMPLANTED OF THE SAME LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980261 ↗
• MalfunctionOct 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -8.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON NOTES THE LENS HAD TORE BEFORE/DURING LOADING. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SAME LENGTH LENS AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17934828 ↗
• MalfunctionOct 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT (B)(6) 2023 A 13.2MM, VICM5_13.2, -08.00 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO PATIENTS LEFT EYE(OS). THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. BACK UP LENS IMPLANTED AND PROBLEM RESOLVED. CAUSE OF THE EVENT IS REPORTED AS DEVICE, USER ERROR; LENS STILL PARTIALLY IN THE INJECTOR WAS REMOVED TO RELOAD, IT WAS FOUND TO HAVE TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862034 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.