Clareon™ CNWTT5 (UDI 00380652469586)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652469586), received between Jun 6, 2022 and Aug 14, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Crack” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Crack1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2023Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORIC INTRAOCULAR LENS (IOL) HAD AN INCORRECT AXIAL POSITION, LEADING TO A SUBOPTIMAL VISUAL OUTCOME. TO ADDRESS THIS ISSUE AND IMPROVE THE UNCORRECTED VISUAL ACUITY, A SURGICAL INTERVENTION WAS PERFORMED TO ROTATE THE INTRAOCULAR LENS TO THE CORRECT POSITION. PREOPERATIVE MEASUREMENTS: - UNCORRECTED VISUAL ACUITY (INCLUDING DATE): DATE ALL OVER THE GLEICHE: (B)(6) 2023: 0.32 DECIMAL. - OPTIMAL CORRECTED VISUAL ACUITY (INCLUDING DATE): 0,8 +. - MANIFEST REFRACTION (INCLUDING DATE): +1,5 /-3,5/12. POSTOPERATIVE MEASUREMENTS: - UNCORRECTED VISUAL ACUITY (INCLUDING DATE): 0.4 DECIMAL ON (B)(6) 2023. - OPTIMAL CORRECTED VISUAL ACUITY (INCLUDING DATE): 0.63 , (B)(6) 2023 - MANIFEST REFRACTION (INCLUDING DATE): +0,75/-1,0/46 FOLLOW-UP ON 25-JUL-2023: UCVA 4M: 0.2 LOGMAR, BCVA 4M: 0.0 LOGMAR. SUBJECTIVE REFRACTION: +0.75/-1.25/44°. IOL IN LOCO, AXIS POSITION SHOULD BE: 84°, IS 78°.
Patient problems: Visual Impairment
MAUDE report 17541408 ↗InjuryJun 6, 2022Crack; Crack
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL ITSELF WAS IN A CRACKED (SHATTERED) STATE WHEN IT WAS IMPLANTED. THE SURGERY WAS COMPLETED AFTER EXPLANTING AND REPLACING THE CRACKED IOL BY ENLARGING THE INCISION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO POTENTIAL HEALTH IMPACT. THE NEXT DAY, THE PATIENT'S VISION WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14603461 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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