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

Model Number	SY60WF
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during an intraocular lens (iol) implant procedure, the lens optic and haptic were found damaged when implanting.It was most likely damaged to begin with.The lens was implanted, then explanted, and the surgery was completed after replacing the product with another one.Additional information was requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol returned positioned incorrectly in the iol case.The lens is returned in 4 segments, with approximately 10% of the optic missing.Solution is dried on the iol.The tip of one haptic is broken and is returned.The other haptic is intact.The optic is torn/split-cut dividing the optic in three segments, with two segments adhered to each other.The optic edge is chipped/damaged in one of the segments of the lens.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.Provided photo 1 shows an yellow single-piece lens being inserted into the loading area of a monarch cartridge.The lens was held by forceps.There appeared to be three areas of edge damage.Provided photo 2 shows a partially implanted iol.The optic and two haptics are visible.The haptics are in a folded position over the lens optic.One haptic tip appears to be broken.The iol optic appears to be chipped along the edge.Two videos were provided.The first video showed a yellow single-piece lens held by forceps being loaded into a monarch cartridge.The lens appeared to have three areas of edge damage, and a damaged haptic tip observed as it was being loaded.This was very hard to see due to glare.Only the cartridge loading area was visible.Ovd amount could not be determined.The lens was inserted into the loading area.The lens was not biased down.The lens was very rapidly advanced with the loading forceps to the nozzle entry area.This video ends.The second video started with the cartridge tip already inserted into the incision.The yellow lens was visible at the parting line.The lens was advanced into the eye.The areas of damage observed on the first video were clearly visible on the optic edge and at the haptic tip.We are unable to determine the root cause for the reported complaint "damaged lens optic and haptic".Video shows significant lens damage prior insertion into the cartridge.The lens has been subjected to handling, no video is available on lens position in the lens case or the lens handling prior insertion into the cartridge.No determination can be made when the damage occurred.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage/condition would not meet our current release criteria.Based on these investigation findings, 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: 22134163
• Report Number: 9612169-2025-01173
• Device Sequence Number: 7314961
• Product Code: HQL
• UDI-Device Identifier: 00380652251457
• UDI-Public: (01)00380652251457(17)270114(11)230116(10)25569020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 25569020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC OVD
• Patient Sex: Unknown