MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implant procedure, having some issues lens being scratched.It happened today with two different techs.But the first time it happened it was in the center of the lens, that one was removed and a new one placed, the second lens had an almost identical mark on it.So it had to be replaced as well.We swapped out cartridges, thinking it could be a flaw in a lot number, but it still happened.It has happened with different sizes and style of lenses, and we have used different instrument sets each time.Additional information has been requested.There are two medical device reports associated with this report.This is 2 of 3.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.A photo was provided of a lens inside the eye.The screen view shows the multiple lines of the monitor screen.The glare from overhead lighting was observed on the lens.All of the optic and the gusset area of one haptic can be viewed in this photo.There appears to be a stutter scratch travelling forward, located near the optic edge.Associated product information was not provided.It is unknown if qualified products were used.A photo was provided of the lens damage.The damage observed was similar in nature to damage detected using cavity 173 company cartridges.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20856435
• Report Number: 1119421-2024-02386
• Device Sequence Number: 20978674
• Product Code: HQL
• UDI-Device Identifier: 00380652251440
• UDI-Public: (01)00380652251440(17)280501(11)240503(10)15842928
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/15/2025

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 Catalogue Number: SY60WF.180
• Device Lot Number: 15842928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 04/15/2025
• Date Device Manufactured: 05/03/2024
• 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: MONARCH III IOL, CARTRIDGE D.
• Patient Sex: Unknown