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

Model Number	CNA0T0
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported that during the intraocular lens (iol) implantation procedure of the right eye, the injector did not work to insert the iol.An alternate cartridge and injector was used to inject the lens the same lens.There was no patient harm.
Additional Manufacturer Narrative
(b)(4).Photo review: photo provided showing company device.There device appears to be not activated.The root cause for the reported complaint may be related to manufacturing issue, however; a definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.The manufacturer internal reference number is:(b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was confirmed.The device was returned loose in the carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.No lens returned.Lever is moving freely.Plunger is not advancing.The device is taken apart for evaluation.Canister is fully punctured.Krytox is observed on the canister neck.No damage observed to o-rings.The device was reloaded and was reactivated with a new canister.The failure mode could not be replicated - the device activated with no issues.The root cause is deemed to be manufacturing related (the faulty sub-assembly was supplied by company's vendor).The product did not meet specifications.During the forensic evaluation, canister was observed to be punctured.Internal parts of the device showed no damage.Possible root causes are: empty gas canister supplied by vendor or unintentional rupture of gas canister.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: 12379600
• Report Number: 9612169-2021-00176
• Device Sequence Number: 17172803
• Product Code: HQL
• UDI-Device Identifier: 00380652393485
• UDI-Public: 00380652393485
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2022

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: 11/30/2021
• Device Model Number: CNA0T0
• Device Lot Number: 21261000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 10/17/2022
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 11/25/2021; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• 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: UNSPECIFIED CARTRIDGE.; UNSPECIFIED INJECTOR.; UNSPECIFIED OVD.; UNSPECIFIED CARTRIDGE; UNSPECIFIED INJECTOR; UNSPECIFIED OVD
• Patient Age: 57 YR
• Patient Sex: Female