CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
Report
- Report Number
- 9612169-2024-01083
- Event Type
- Injury
- Date Received
- October 28, 2024
- Report Date
- January 3, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- HQL
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. 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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
CORRECTION INFORMATION WAS PROVIDED IN H.6 AND H.11. FDA EVALUATION CODE B14 WAS SENT INSTEAD OF B22. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPERIENCED HALOS AT NIGHT AND UNABLE TO DRIVE AT NIGHT DUE TO THE HALOS. ALSO SEEKING A SECOND OPINION AND MAY HAVE LENS REMOVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1959314 | CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS | LENS, MULTIFOCAL INTRAOCULAR | HQL | ALCON LABORATORIES IRELAND LTD. | NI | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |