FDA Adverse Event
Malfunction
Summary report: N
CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
MDR report key: 23693938
·
Received December 2, 2025
Report
- Report Number
- 9612169-2025-02408
- Event Type
- Malfunction
- Date Received
- December 2, 2025
- Date of Event
- October 23, 2025
- Report Date
- December 2, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- HQL
- UDI-DI
- 00380652393799
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT LENS COMES WITH LEGS STRETCHED. UNSPECIFIED CLARIFIED LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2850375 | CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM | INTRAOCULAR LENS | HQL | ALCON LABORATORIES IRELAND LTD. | CNA0T0 | 26068437 | 00380652393799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |