Clareon TruPlus RECAT4 (REF RECAT4.190)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TRUPLUS TORIC UVA ATME · Class 3 · Implant
Data updated Oct 18, 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 00380658535957), received between Sep 16, 2026 and Sep 18, 2026 — classified as 2 injuries.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Visual Impairment2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, the patient underwent lens exchange with a different unspecified model. The IOL was explanted in the secondary implant procedure.Additional information has been requested but is not available at the time of this report.There are two medical reports associated with this patient. This is for right eye.
Patient problems: Visual Impairment
MAUDE report 50813636 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, the patient underwent lens exchange with a different unspecified model. The IOL was explanted in the secondary implant procedure.Additional information has been requested, received and stated the lens was exchanged due to refractive error. The lens was exchanged with different model same diopter company lens. There was no further patient impact.There are two medical reports associated with this patient. This is for left eye.
Patient problems: Visual Impairment
MAUDE report 50790731 ↗
Other Lens, Intraocular, Toric Optics devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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