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

Model Number	SY60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, that the lens was deformed.Additional information has been received that during the movement of the iol through the cartridge even before entering the narrow part of the cartridge posterior haptic was separated when advanced the lens.There was no sticking of the haptics to the plunger.There was no patient contact.
Additional Manufacturer Narrative
A product 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).
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.The reported complaint was observed on the returned photo.Provided photo shows an iol outside the lens case against unknown background.One haptic appears to be broken and folded over the optic of the lens.The complainant indicates the use of non-company as a viscoelastic which is not qualified for use with the associated iol model based on our observation of the attached photo, one haptic appears to be broken and folded over the optic of the lens.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instructions for use (ifu), as the reporter states the use of non-qualified viscoelastic.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 22187328
• Report Number: 9612169-2025-01213
• Device Sequence Number: 18296929
• Product Code: HQL
• UDI-Device Identifier: 00380652251556
• UDI-Public: (01)00380652251556(17)270604(11)230606(10)25653553
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Model Number: SY60WF
• Device Lot Number: 25653553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 06/06/2023
• 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: KOGEVISK.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.
• Patient Age: 76 YR
• Patient Sex: Female