FDA Adverse Event
Injury
Summary report: N
CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL
MDR report key: 20688791
·
Received November 14, 2024
Report
- Report Number
- 1119421-2024-02222
- Event Type
- Injury
- Date Received
- November 14, 2024
- Report Date
- November 14, 2024
- Manufacturer
- ALCON RESEARCH, LLC - HUNTINGTON
- Product Code
- POE
- UDI-DI
- 00380652405744
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY VISION AND MORE ASTIGMATISM THAT EXPECTED. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 19 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1351454 | CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL | EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS | POE | ALCON RESEARCH, LLC - HUNTINGTON | CCWET0 | 15354507 | 00380652405744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | REPLACEMENT LENS: UNSPECIFIED ATIOL. |