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

Model Number CNA0T0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Visual Impairment (2138)

Event Date 03/03/2022

Event Type  Injury  

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 Description

A physician reported that following a cataract surgery with intraocular lens (iol) implant procedure, the patient experienced unexpected refractive outcome.The iol was exchanged with an alternate iol in a secondary procedure.Additional information was received and stated that after a secondary surgery, same lens was implanted, with the same diopter and the postop result refraction is 0.Biometer calculations was fine and the surgeon has more confidence that the power of the first iol was not +24.0 d.

Manufacturer Narrative

The product was returned for analysis.The lens was received in a specimen container with an unknown solution.The lens was received in one piece.No damage observed.No identification of the product received (no labels, no carton, no company device).Additional information: power and resolution test was performed showing 17.5d lens (see attached).The root cause is deemed to be manufacturing related.Incorrectly labeled product was released.Internal investigation was raised as part of this investigation.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
• Type of Device: 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: 14349450
• MDR Text Key: 291327546
• Report Number: 9612169-2022-00220
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393799
• UDI-Public: 00380652393799
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 25238775
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female