CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
Report
- Report Number
- 9612169-2025-01558
- Event Type
- Malfunction
- Date Received
- August 6, 2025
- Report Date
- December 12, 2025
- Manufacturer
- ALCON LABORATORIES IRELAND LTD.
- Product Code
- HQL
- UDI-DI
- 00380652393614
- PMA / PMN Number
- P190018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- 003
Narratives
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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
ADDITIONAL INFORMATION PROVIDED IN B.5., D9, H.3., H.6. AND H.11. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. 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.
ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6., AND H.11. THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT "LENSES KEPT GOING FORWARD DESPITE FINGERS LIFTED OFF" WAS NOT OBSERVED. THE PRODUCT WAS NOT RETURNED IN THE REPORTED CONDITION. PRODUCT CARTON WAS RECEIVED WITH A NOTE "NO IMPLANTED, DAMAGED". THE DEVICE WAS RETURNED IN AN OPENED BLISTER TRAY. THE LOCK-OUT ASSEMBLY HAS BEEN REMOVED. THE PIN STOP IS BROKEN AND IS STUCK IN THE LENS BAY DOOR IN THE PIN STOP DESIGNATED AREA. SOLUTION IS DRIED IN THE DEVICE. THE DEVICE WAS RECEIVED ACTIVATED. THE LENS IS CRUSHED AROUND THE BROKEN PIN STOP AND THE PLUNGER IS ADVANCED TO BETWEEN MID-NOZZLE AND THE DEPTH GUARD. THE RETURNED SAMPLE WAS OBSERVED TO HAVE A DIFFERENT ISSUE THAN REPORTED. THE CUSTOMER REPORTED SEVERAL PRODUCTS UNDER IDENTICAL DESCRIPTION. NO CLARIFICATION WAS RECEIVED FROM THE REPORTER. PRODUCT CARTON WAS RECEIVED WITH A NOTE "NO IMPLANTED, DAMAGED". ON THE EVALUATION OF THE PRODUCT IT WAS DETERMINED THAT THE ISSUE IS RELATED TO A BROKEN PIN STOP. THE PRODUCT DID NOT MEET SPECIFICATIONS. THE LENS PIN STOP WAS FOUND TO BE BROKEN AND STUCK IN THE LENS BAY DOOR IN THE PIN STOP DESIGNATED AREA. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. 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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE THE LEVER WAS PRESSED DOWN ON THE PRELOADED DELIVERY SYSTEM, THE LENS KEPT ADVANCING FORWARD DESPITE FINGERS BEING LIFTED OFF. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
ADDITIONAL INFORMATION WAS RECEIVED AND STATED BASED ON THE QUERY RAISED. IT STATED THAT THE RETURNED SAMPLE SHOWED A BROKEN PIN STOP, WHICH APPEARED TO BE A DIFFERENT ISSUE THAN WHAT WAS ORIGINALLY REPORTED. THE REPORTER WAS NOT SURE WHETHER THIS HAPPENED DURING THE INCIDENT OR AFTERWARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1555319 | CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM | INTRAOCULAR LENS | HQL | ALCON LABORATORIES IRELAND LTD. | CNA0T0 | 25783215 | 00380652393614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |