MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CCA0T0
Medical Device Problem Codes	Inaccurate Delivery (2339); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, it was noticed that the lens was kept in the loader incorrectly so when the lens was injected it went into the patients eye upside down.The surgeon cut the lens into half to remove it.Lens was explanted and replaced with another company lens during the initial procedure.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Correction information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported via fda medsun mandatory and voluntary report form that during an intraocular lens (iol) implant procedure, it was noticed that the lens was kept in the loader incorrectly so when the lens was injected it went into the patients eye upside down.The surgeon cut the lens into half to remove it.Lens was explanted and replaced with another company lens during the initial procedure.There was no patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Correction information provided in h.10.Correction: in the initial mdr submission, the medwatch report number was not updated in section h.10.This has now been corrected and included in the supplementary medical device report.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22434487
• Report Number: 9612169-2025-01351
• Device Sequence Number: 4592891
• Product Code: HQL
• UDI-Device Identifier: 00380652397339
• UDI-Public: (01)00380652397339(17)271125(11)231127(10)25759640
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CCA0T0
• Device Lot Number: 25759640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 11/17/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/22/2025; 11/18/2025
• Date Device Manufactured: 11/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female