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

Model Number	SY60WF
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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 photo provided shows the lens outside the lens case well area and on the lens case base.Due to the angle and poor clarity of the photo, we cannot confirm the reported damage and we are unable to determine handling.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A healthcare professional reported that before an intraocular lens (iol) implant procedure, it was noticed that outer end surface was missing from the lens haptic when the lens had just been folded into the cartridge.There was no patient contact.The procedure was not significantly delayed and was then completed with a unspecified replacement lens of the same power.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in h.6.On initial mdr the product code should be a0401 instead of a0202.Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.One haptic was broken in the distal tip area (not returned).The photo provided appears to be of the returned sample.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and handpiece with a non-qualified viscoelastic.The reported lens damage was observed.The root cause for the observed lens damage may be related to failure to follow the ifu.The file indicated the use of a non-qualified viscoelastic.The ifu instructs that an alcon qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• 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: 21302940
• Report Number: 1119421-2025-00291
• Device Sequence Number: 8848054
• Product Code: HQL
• UDI-Device Identifier: 00380652251563
• UDI-Public: (01)00380652251563(17)280206(11)240208(10)15795627
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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.240
• Device Lot Number: 15795627
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: CLAREON MONARCH IV INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; OVD: PROTECTALON
• Patient Sex: Unknown