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

Model Number	CNA0T0
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.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.There was two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported that during a cataract extraction with intraocular lens (iol) implant procedure, the intraocular lens (iol) came out of the patient¿s eye at the time of the injection.The incident occurred during the implant introduction into the patient's eye.The device touched the patient's eye.Another implant was used.There were no clinical consequences observed for the patient.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in the blister tray in the carton.The lock-out assembly has been removed.The plunger is oriented correctly.The correct nozzle confirmed on the device.Viscoelastic is observed in the device.The plunger has been advanced at the wound guard.A few iol (intraocular lens) segments are observed around the plunger tip.No iol returned.The product investigation could not identify the root cause for the reported complaint "the implant came out of the eye at the time of the injection".The plunger was observed to be advanced at the wound guard, a few iol segments are observed around the plunger tip.If the plunger is not fully advanced, the iol may not release properly from 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: 13363778
• Report Number: 9612169-2022-00024
• Device Sequence Number: 20129897
• Product Code: HQL
• UDI-Device Identifier: 00380652396479
• UDI-Public: 00380652396479
• 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): 04/01/2022

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: 03/31/2022
• Device Model Number: CNA0T0
• Device Lot Number: 21269869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2020
• 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 Sex: Unknown