Clareon™ CC60WF (UDI 00380652396981)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon™ Aspheric UV Absorbing IOL - STERILE UV-Absorbing Hydrophobic Acrylic Foldable Aspheric 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652396981), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Capsular Bag Tear1
- Corneal Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2022Break; Break
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, UPON IMPLANTATION THE HAPTIC DETACHED FROM THE OPTIC. SURGEON HAD TO EXPLANT LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, WHEN THE HAPTICS UNFOLDED, THAT'S WHEN THE SURGEON NOTICED THE BROKEN HAPTICS AND PROCEEDED TO CUT THE LENS OUT FOR A REPLACEMENT LENS OF SAME DIOPTER. HOWEVER, THE CAPSULE BAG WAS STUCK TO THE BROKEN PIECES AND PROCEEDED TO RIP THE BAG APART. THE SURGEON PROCEEDED TO LEAVE THE PATIENT APHAKIC AND DISCHARGED.
Patient problems: Capsular Bag Tear; Corneal Edema
MAUDE report 15321924 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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