Clareon™ CC60WF (UDI 00380652396820)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00380652396820), received between Jun 22, 2022 and Jun 12, 2026 — classified as 7 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (10 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS HAD NOTCHES ON THE BACK OF THEM. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 3. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482835 ↗
• MalfunctionJun 1, 2026Material Discolored

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A VERY SMALL FOREIGN BODY WAS FOUND WITHIN THE LENS, EXHIBITING A METALLIC SHEEN NEAR THE HAPTIC, APPROXIMATELY THE SIZE OF A TORIC MARKING. THE FINDING WAS NOTED IMMEDIATELY AFTER IMPLANTATION, AND HE ATTEMPTED TO POLISH IT WITHOUT SUCCESS. THE FOREIGN BODY DID NOT APPEAR METALLIC. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT HAD A NORMAL POSTOPERATIVE COURSE. AFTER INSERTING THE LENS, IT WAS NOTED THAT THERE WAS A SQUARE-SHAPED REFRACTIVE OPACITY THAT APPEARED TO BE WITHIN THE LENS ADJACENT TO THE OPTIC. TO ENSURE THAT THE OPACITY WAS NOT ON THE SURFACE, THE SURGEON USED A SOFT-TIP IRRIGATION AND ASPIRATION HANDPIECE OVER THE AREA ON BOTH THE FRONT AND BACK OF THE LENS, WITHOUT ANY MOVEMENT OF THE OPACITY. THE SURGEON THEN USED A HOOK AND DRAGGED IT ACROSS THE OPACITY SEVERAL TIMES, AND IT GLIDED SMOOTHLY ACROSS THE AREA AS IT WOULD OVER THE REST OF THE LENS. THIS LED TO THE BELIEF THAT THE OPACITY WAS WITHIN THE LENS ITSELF. THE SURGEON DID NOT WANT TO REMOVE THE LENS IF THE OPACITY WAS NOT CAUSING HARM. THE SURGEON DISCUSSED THIS WITH THE PATIENT AND LEFT THE LENS IN THE EYE, WITH A PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351131 ↗
• MalfunctionMay 25, 2026Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED CRACKED LENS. THE LENS WAS REMOVED AND SURGERY COMPLETED SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272125 ↗
• MalfunctionApr 27, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THREE LENSES WERE USED, AND THE HAPTICS WERE TORN OFF UPON DELIVERY. THE LENSES WERE NOT TORN UPON REMOVAL FROM THE PACKAGING BUT AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25001572 ↗
• MalfunctionApr 27, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THREE LENSES WERE USED, AND THE HAPTICS WERE TORN OFF UPON DELIVERY. THE LENSES WERE NOT TORN UPON REMOVAL FROM THE PACKAGING BUT AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25001569 ↗
• MalfunctionApr 27, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THREE LENSES WERE USED, AND THE HAPTICS WERE TORN OFF UPON DELIVERY. THE LENSES WERE NOT TORN UPON REMOVAL FROM THE PACKAGING BUT AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25001566 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, IT WAS NOTICED THAT THERE WAS THICK CRACK IN LES. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SURGERY WAS COMPLETED AFTER REPLACING THE LENS WITH A BACK UP LENS DURING THE SAME PROCEDURE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895836 ↗
• InjuryApr 13, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED AN UNSPECIFIED ISSUE WITH IMPLANT/ EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED AFTER LENS WAS INJECTED INTO CAPSULAR BAG, LENS WAS NOTED TO BE TILTED, AND A POSTERIOR CAPSULAR RUPTURE WAS NOTED, LENS WAS CUT, REMOVED AND REPLACED WITH ANOTHER MODEL COMPANY LENS DURING INITIAL PROCEDURE, AND AN ANTERIOR VITRECTOMY WAS PERFORMED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24861967 ↗
• MalfunctionMar 30, 2026Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, SCRATCHES ON THE OPTIC PERIPHERY WERE NOTICED. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24712777 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS TEAR IN THE CAPSULE AND THEREFORE, THE DOCTOR CHOSE ANOTHER LENS TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Capsular Bag Tear

  MAUDE report 24712363 ↗
• MalfunctionMar 13, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE SCRATCHED ON DELIVERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24588816 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED DIFFICULTY WITH DEPTH PERCEPTION. THE PATIENT STATED THAT THE GROUND APPEARED UNEVEN AND THAT JUDGING LEVEL SURFACES (E.G., WHILE RAKING THE GARDEN) WAS DIFFICULT. THE PATIENT ALSO REPORTED THAT THEIR VISION SEEMED TO BE WORSENING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Impairment; Vitreous Floaters

  MAUDE report 24469981 ↗
• MalfunctionJan 15, 2026Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT UNFOLD. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077461 ↗
• MalfunctionJan 13, 2026Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT UNFOLD. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052725 ↗
• MalfunctionDec 29, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY NOTICED THAT THE IOL WAS DEFORMED, IT HAD DOUBLE HAPTICS ON ONE SIDE. THE LENS WAS NOT IMPLANTED. ACCORDING TO THE ADDITIONAL DETAILS PROVIDED, THE EVENT OCCURRED DURING THE LOADING PROCESS. THERE WAS NO CONTACT WITH THE PATIENT, AND THE PRODUCT WAS DISCARDED. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905224 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 27 DAYS FOLLOWING THE INITIAL PROCEDURE. THE IOL WAS REPLACED WITH MONOFOCAL LENS.

  Patient problems: Visual Impairment

  MAUDE report 23791420 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER UNDERGOING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, HIS VISION BECAME SIGNIFICANTLY WORSE THAN BEFORE. HE EXPERIENCED SEVERE DIFFICULTY SEEING IN ALL LIGHTING CONDITIONS, WITH CONSTANT GLARE. HE DESCRIBED HIS VISION AS SIMILAR TO LOOKING THROUGH A HANDKERCHIEF AND NOTED EXCESSIVE LIGHT PERCEPTION. HE WAS UNABLE TO SEE CLEARLY AT A DISTANCE. HE COULD FOCUS MORE CLOSELY AT APPROXIMATELY A ONE-YARD DISTANCE, THOUGH THIS WAS INCONSISTENT. SOMETIMES HE COULD FOCUS AND SOMETIMES COULD NOT. HE ALSO REPORTED THAT IMAGES APPEARED APPROXIMATELY ONE-THIRD TO ONE-HALF SMALLER COMPARED TO HIS LEFT EYE. TWO MONTHS POST-SURGERY, HIS VISION HAD NOT IMPROVED. HE STATED THAT LOOKING THROUGH THE AFFECTED EYE FELT LIKE VIEWING THROUGH A TELESCOPE BACKWARDS - IMAGES APPEARED SMALLER AND FARTHER AWAY THAN THEY ACTUALLY WERE. HIS DOCTOR ATTEMPTED AN YTTRIUM-ALUMINUM-GARNET (YAG) LASER PROCEDURE TO REDUCE GLARE, BUT IT HAD NO EFFECT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 23777041 ↗
• MalfunctionSep 18, 2025Break; Break

  A NURSE REPORTED THAT DURING THE CATARACT SURGERY INTRAOCULAR LENS (IOL) IT WAS FOUND THAT, THE HAPTIC WAS SEVERED. BROKEN HAPTIC WAS NOTED ONCE LENS WAS IN THE EYE. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED THE SAME DAY WITH THE NEW REPLACEMENT LENS. INCISION WAS NOT ENLARGED TO EXPLANT THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085318 ↗
• MalfunctionSep 4, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC WAS BROKEN. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STARTED THAT THE LENS WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE AND REPLACED WITH SAME DIOPTER AND MODEL COMPANY LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961580 ↗
• MalfunctionAug 18, 2025Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT CONTACT. ANOTHER UNSPECIFIED LENS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828367 ↗
• MalfunctionJul 23, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE DEFECT ON LENS OPTIC. AS PER THE SURGEON¿S OPINION, POSSIBLE BENT INSERTER CAUSING DEFECT DURING LOADING AND INJECTING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING THE LENS WITH ANOTHER LENS FROM THE SAME COMPANY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579049 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MIGRAINES AND ANISOMETROPIA. THE IOL WAS EXCHANGED FOR SAME MODEL WITH 2.5 MORE DIOPTER COMPANY LENS. PATIENT'S ISSUE WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Headache; Visual Disturbances

  MAUDE report 22575184 ↗
• MalfunctionJul 14, 2025Break; Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS TORN/BROKEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED, IN SURGEONS OPINION THE CAUSE OF THE EVENT WAS POSSIBLE PRIOR TO TECHNICIAN TOUCHING IT. ALSO POSSIBLE TECHNICIAN TORE IT WHILE ATTEMPTING TO LOAD THE LENS. SURGEON WAS UNSURE IF IT WAS TORN PRIOR OR TORN DURING TECHNICIAN HANDLING. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495346 ↗
• MalfunctionJun 23, 2025Break; Break

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BEFORE LOADING THE LENS, THE TRAILING HAPTIC BROKE OFF WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH SAME MODEL SAME DIOPTER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308703 ↗
• MalfunctionMay 14, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED STATING, HAPTIC WAS BROKEN WHICH WAS NOTICED WHEN IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22017242 ↗