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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
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 non-healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed that the lens was scratched after implanting the lens.The lens was explanted and replaced with another lens during initial procedure.The procedure was completed on same day.Additional information has been received and stated that, there is no patient harm reported.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.The optic has scratches and scuff marks in the shape of an instrument used to grasp the lens on the anterior and posterior sides of the lens.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.Scratches and scuff marks in the shape of an instrument used to grasp the lens were observed.All lenses are 100 percentage inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met completed release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of blood, surgical solution, and the condition of the returned sample, the damage is most likely related to customer handling.The instruction for use (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 ophthalmic viscosurgical device (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 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.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens (iol) to stay in the folded condition.Failure to adhere to manufacturer's recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.File will be reopened when new information or the product is received.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: 19095905
• Report Number: 1119421-2024-00691
• Device Sequence Number: 17958980
• Product Code: HQL
• UDI-Device Identifier: 00380652251570
• UDI-Public: 00380652251570
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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.245
• Device Lot Number: 15723334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: CLAREON MONARCH IV INJECTOR; MONARCH IIICARTRIDGE D; VISCOAT
• Patient Age: 58 YR
• Patient Sex: Male