FDA Adverse Event
Malfunction
Summary report: N
CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM
MDR report key: 22488701
·
Received July 12, 2025
Report
- Report Number
- 9612169-2025-01377
- Event Type
- Malfunction
- Date Received
- July 12, 2025
- Report Date
- October 7, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- HQL
- UDI-DI
- 00380652397421
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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).
Additional Manufacturer Narrative · 0
ON INITIAL MDR THE FDA PRODUCT PROBLEM CODES OF A150101 AND A1501 WERE INCORRECT. IT SHOULD HAVE BEEN A140504 ON THE ORIGINAL MDR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem · 0
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TECH STOPPED PRESSING THE LEVER AND FOR UNKNOWN REASON AND THE LENS CONTINUED MOVE FORWARD, AND CO2 CONTINUED FLOW. ADDITIONAL INFORMATION REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653391 | CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM | INTRAOCULAR LENS | HQL | ALCON LABORATORIES IRELAND LTD. | CCA0T0 | 25766849 | 00380652397421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |