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)
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).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, the lens was scratched.Additional information has been requested.There are two medical device reports associated with this report.This is 2 of 2.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.The assembled empty lens case was returned.The lens was not returned.A photo was provided that showed a partial view of an implanted single piece lens.A short scratch was visible on the anterior surface at the optic haptic junction area.This mark is angled to the travel path.Damage to the anterior surface is typically caused by forceps or the plunger.The anterior surface of the lens does not contact the cartridge lumen if the lens is loaded or folded correctly.An empty company cartridge pouch was returned.Product history records were reviewed and documentation indicated both products met release criteria.A qualified cartridge was indicated.It is unknown if a qualified handpiece and viscoelastic were used.The root cause could not be determined.The sample was not returned.Based on review of the provided photo the lens was scratched.A short scratch was visible on the anterior surface at the optic haptic junction area.This mark was angled to the travel path.Damage to the anterior surface is typically caused by forceps or the plunger.The anterior surface of the lens does not contact the cartridge lumen if the lens is loaded folded correctly.The instruction for use (ifu) instructs: company foldable intra ocular lens (iols) 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 ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.File will be reopened if new information or the sample is received.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: 21623203
• Report Number: 1119421-2025-00710
• Device Sequence Number: 12873302
• Product Code: HQL
• UDI-Device Identifier: 00380652251464
• UDI-Public: (01)00380652251464(17)280814(11)240816(10)15908406
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/18/2025

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.190
• Device Lot Number: 15908406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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 CARTRIDGE D; MONARCH INJECTOR, UNSPECIFIED
• Patient Sex: Unknown