Clareon™ CCA0T0 (UDI 00380652397261)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens with the AutonoMe™ Automated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652397261), received between Jun 27, 2023 and May 12, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Inaccurate Delivery” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inaccurate Delivery3
- Failure to Deliver2
- Crack1
- Defective Device1
- Device Damaged by Another Device1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WENT PAST THE INSERTER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PATIENT ISSUES WERE RESOLVED. THERE WAS PATIENT CONTACT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148425 ↗MalfunctionJan 29, 2026Material Split, Cut or Torn
A NURSE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED FOUND SMALL TEAR ON LENS AFTER PACKAGED OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208921 ↗MalfunctionDec 15, 2025Inaccurate Delivery; Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INSERTER DELIVERED THE LENS UPSIDE DOWN. THE SURGEON WAS ABLE TO MANIPULATE THE LENS TO GET IT TURNED RIGHT-SIDE-UP AND THE LENS DID NOT NEED EXPLANTED, THEY WAS ABLE TO STILL USE THE LENS AS INTENDED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802678 ↗MalfunctionNov 19, 2025Inaccurate Delivery; Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS STATED THAT IOL CAME ACCIDENTALLY AND THE DEVICE MALFUNCTIONED. IT WAS ALSO STATED THAT THERE WAS NO PATIENT ISSUE AND ANOTHER DEVICE WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23595623 ↗MalfunctionNov 6, 2025Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS IMPLANTED SUCCESSFULLY BUT THE CRACK ON THE BLUE PLUNGER.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23485865 ↗MalfunctionFeb 18, 2025Failure to Deliver; Failure to Deliver
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT ADVANCE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IN THE SURGEON¿S OPINION LENS WOULD NOT ADVANCE IN THE CARTRIDGE BECAUSE IT FLIPPED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397010 ↗MalfunctionFeb 27, 2024Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT A ¿CHUNK OF THE LENS WAS MISSING DURING IMPLANTATION.¿ THEY TOLD THAT THE SCRUB TECH FILLED WITH VISCOELASTIC AND HANDED IT TO THE SURGEON TO ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THIS FILE IS FOR THE LEFT EYE.
Patient problems: Insufficient Information
MAUDE report 18788559 ↗MalfunctionJun 27, 2023Inaccurate Delivery; Defective Device; Inaccurate Delivery; Defective Device
A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE INTRAOCULAR LENS CAME OUT IN AN UNUSUAL MANNER. TECHNICIAN WAS CONCERNED PLUNGER APPEARED MISALIGNED. LENS WAS INSERTED INTO THE EYE WITHOUT INCIDENT. IOL APPEARS TO BE UNAFFECTED AND IN GOOD CONDITION. SURGERY WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17209202 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- 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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