MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Codes	Defective Component (2292); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during cataract surgery with intraocular lens (iol) implant procedure, proximal haptic broke.During lens progression in eye, the haptic was caught by the injector and split at the base.Implant entered the anterior chamber and had to be explanted by widening the incision.The procedure was competed with new iol.
Additional Manufacturer Narrative
On initial mdr the fda product problems 2524 was an erroneously submitted.The product was returned for analysis and the reported damage was observed.Iol returned adhered to the inside of a sample container.A significant amount of solution is dried on the iol.One haptic is broken/torn and is returned, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable with a piece missing.The product investigation could not identify the root cause for the reported complaint "broken during injection".Only the iol was returned for evaluation.No cartridge was returned.Due to this, we are unable to complete a thorough investigation to determine a root cause.The reported complaint is lacking in relevant information such as associated products used to complete a thorough investigation.Due to the lack of information, we are unable to verify if the iol contributed to the event.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
• 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: 17641064
• Report Number: 9612169-2023-00616
• Device Sequence Number: 15468733
• Product Code: HQL
• UDI-Device Identifier: 00380652251594
• UDI-Public: 00380652251594
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 01/25/2025
• Device Model Number: SY60WF
• Device Lot Number: 25263249
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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; DUOVISC
• Patient Age: 83 YR
• Patient Sex: Male