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

Model Number	CC60WF
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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.There have been no other complaints reported in the lot number.Information was provided that a non-qualified handpiece was used.The replacement lens was implanted with the qualified handpiece with no issue observed.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, the 5 little cracks was observed in optic, the lens was cut in half and removed.A replacement lens was used, and everything was fine.Additional information has been requested and received and was further clarified that the lens had five scratches in the visual axis.The surgery was completed on the same day with a replacement lens.As per the surgeon the cartridge may have had defects that scratched the surface of the lens as the lens moved through the cartridge.The lens was in the injector for about three minutes and sufficient amount of viscoelastic was used.
Additional Manufacturer Narrative
The product was not returned.A photo was provided of a monofocal lens in the eye.Small marks were indicated with a red arrow.The marks appeared to be on the anterior surface.The marks had the appearance of narrow scratches or cracks.Damage on the anterior surface would be unrelated to the cartridge.If the lens is folded properly, the anterior surface does not contact the cartridge inner surface.A pressure mark was observed on the right side of the optic at the edge, possibly a plunger or forcep mark.If it was a plunger mark, the lens was shifted off center in the cartridge.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.Based on the provided photo the lens was damaged.It was indicated "enough" viscoelastic was used and the lens was in the cartridge for three minutes.The replacement lens was implanted with no issues.The ifu (instructions for use) instructs to completely fill the cartridge with ovd (ophthalmic viscosurgical devices) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd (ophthalmic viscosurgical devices) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd (ophthalmic viscosurgical devices), which may result in damage.Follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in intraocular lens damage.Ifu (instructions for use) note: during lens loading and insertion, do not allow the company intraocular lens to remain in a folded condition within the selected intraocular lens delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING 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: 16458255
• Report Number: 1119421-2023-00371
• Device Sequence Number: 20445362
• Product Code: HQL
• UDI-Device Identifier: 00380652396943
• UDI-Public: 00380652396943
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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 Expiration Date: 02/07/2026
• Device Model Number: CC60WF
• Device Lot Number: 15351685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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 INJECTOR.; MONARCH IIICARTRIDGE C.; PROVISC.
• Patient Sex: Unknown