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

Model Number	SY60WF
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 lead ophthalmic nurse reported that during an intraocular lens (iol) implant procedure, a small scuff was noticed on the center of lens.A plastic foreign object was apparently found in the eye as well.This required an iol exchange.The foreign object looked like a post from the bottom half of the wagon wheel cassette.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
Iol case cover returned, cartridge returned, fragment of plastic material returned.No iol.Only lens case lid returned, no lens case base returned.Foreign material sent to lab for further evaluation.The sample was sent to particulate laboratory for testing.Comparison of the particle's generated spectra to a library of spectra found the best match to be polypropylene.The complainant indicates the use of company cartridge, which is not qualified for use with associated iol diopter.The root cause for the reported complaint could not be determined.Based on the spectral comparison results, the best match was found to be polypropylene.Polypropylene is a commonly used material in many medical products.The origin of the material could not be determined.No lens case base was returned, no further analysis of the reported complaint can be made at this time.In addition to this, the customer has reported a scratch on the lens.No iol was returned.The scratch may be related to failure to follow ifu (instructions for the use) as the customer has indicates the use of non qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 16884122
• Report Number: 9612169-2023-00348
• Device Sequence Number: 6092328
• Product Code: HQL
• UDI-Device Identifier: 00380652251600
• UDI-Public: 00380652251600
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 05/23/2026
• Device Model Number: SY60WF
• Device Lot Number: 25421148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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: CLAREON MONARCH IV, INJECTOR.; MONARCH III, CARTRIDGE D.
• Patient Sex: Unknown