FDA Adverse Event
Malfunction
Summary report: N
CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
MDR report key: 22932099
·
Received September 2, 2025
Report
- Report Number
- 9612169-2025-01745
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Date of Event
- August 7, 2025
- Report Date
- November 12, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- HQL
- UDI-DI
- 00380652393737
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
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).
Additional Manufacturer Narrative · 0
CORRECTION INFORMATION WAS PROVIDED IN H.6. (FDA PRODUCT CODE A140504 ADDED). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WENT IN UPSIDE DOWN AND WAS TWISTING IN THE EYE AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2222235 | CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM | INTRAOCULAR LENS | HQL | ALCON LABORATORIES IRELAND LTD. | CNA0T0 | 26015527 | 00380652393737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN VISCOELASTIC |