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

Model Number	CNA0T0
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
A pharmacist reported that during an intraocular lens (iol) implant procedure, defective.The procedure was completed with back up lens.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in d.4.Additional information was provided in d.9.,h.3., h.6.And h.11.The product was returned for analysis and the reported complaint could not be confirmed.Iol was not returned.Only the device was returned.The reported complaint is lacking in relevant information such as the type of defect/issue observed.The device was returned loose in the carton.The lock-out assembly has been removed.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.No damage or abnormalities observed.No iol(intraocular lens) returned.The product investigation could not identify the root cause for the reported complaint "defective".The lens was not returned.Only the device was returned for evaluation.Due to this, we are unable to confirm the lens and the plunger position for advancement.The reported complaint is lacking in relevant information such as the type of defect/issue observed.Due to the lack of information, we are unable to verify if the product contributed to the event.No damage was observed to the device.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE 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: 19858835
• Report Number: 9612169-2024-00756
• Device Sequence Number: 7421322
• Product Code: HQL
• UDI-Device Identifier: 00380652393614
• UDI-Public: (01)00380652393614(17)260607(11)230609(10)25652912
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 Expiration Date: 06/07/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25652912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM
• Patient Age: 69 YR
• Patient Sex: Female