FDA Adverse Event
Malfunction
Summary report: N
CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
MDR report key: 22003889
·
Received May 12, 2025
Report
- Report Number
- 1119421-2025-01359
- Event Type
- Malfunction
- Date Received
- May 12, 2025
- Date of Event
- December 5, 2024
- Report Date
- May 12, 2025
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- HQL
- UDI-DI
- 00380652251501
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- 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).
Description of Event or Problem · 0
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD AS IOL SCRATCHED/WASTED AND EXPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392772 | CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LLC - HUNTINGTON | SY60WF | 15851531 | 00380652251501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |