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

Model Number	SY60WF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that after an intraocular lens (iol) implant procedure, it was noticed that lens optic broken/cracked/split/torn.Additional information has been requested.
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).
Event or Problem Description
Additional information has been stated the procedure was completed on same day.
Additional Manufacturer Narrative
Correction information was added in h.6.The lens was returned in the lens case.Solution was dried on the lens.The optic was broken at one optic/haptic junction area, broken portion not returned.The lens was cleaned with keratometry reading power (klrp) for further evaluation.The lens has cracks and scratches at the damaged gusset area.There is a long scratch on the anterior surface of the optic with a small, cracked area.There was also a stutter-type scratch on the posterior optic surface on the opposite side from the broken optic.The damage at the optic/haptic junction and long scratch on the anterior surface may indicate a plunger override occurred.A non-qualified cartridge was indicated with a qualified handpiece an viscoelastic.The root cause for the lens damage appears to be related to a failure to follow the instructions for use (ifu).The company, 26.5 diopter lens is only qualified for use with the company cartridge as designated on the carton label and the lens case label.The ifu instructs: company foldable intraocular lens (iol)s are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company 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 damage to the optic junction may have been caused by a plunger override.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.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; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21054013
• Report Number: 1119421-2025-00005
• Device Sequence Number: 8656693
• Product Code: HQL
• UDI-Device Identifier: 00380652251617
• UDI-Public: (01)00380652251617(17)280416(11)240418(10)15840519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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.265
• Device Lot Number: 15840519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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 IOL INJECTOR; MONARCH II LOADING FORCEPS; MONARCH III IOL CARTRIDGE D; PROVISC OVD
• Patient Age: 77 YR
• Patient Sex: Female