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

Model Number	CC60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implant procedure, it was found that iol was scratched.The iol replaced with another iol during initial procedure additional information received and stated that the patient was not hospitalized for the event and there was no patient harm.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received.And stated, that no suture was added.
Additional Manufacturer Narrative
The lens and the associated company cartridge were returned inside a plastic specimen cup with screw top lid.Only two cut portions of the lens were returned.Solution was observed dried on the lens pieces.The optic was scratched on the anterior and the posterior near the center.The cut portions had additional cracked areas.The optic edge has a nicked area.The used non-qualified company cartridge has an inadequate amount of viscoelastic observed.The cartridge tip has stress lines.The cartridge wings display evidence of handpiece use.The account indicated the use of a non-qualified cartridge.The diopter of this company lens (26.0 diopter) is beyond the range that has been qualified for use in a company cartridge.A handpiece and viscoelastic were indicated that are qualified when used with this lens and a qualified company cartridge combination.The reported scratch damage was observed.The root cause is most likely related to a failure to follow the ifu (instructions for use).The company lens has been qualified for diopters 6.0 through 25.0 with a company, and diopters 25.5 through 30.0 are qualified for use in the company cartridge.Per the ifu: the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.Also an inadequate amount of viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ovd (diagram provided) 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 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: 15427672
• Report Number: 1119421-2022-01963
• Device Sequence Number: 4750140
• Product Code: HQL
• UDI-Device Identifier: 00380652396943
• UDI-Public: 00380652396943
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 12/28/2022

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: 11/17/2025
• Device Model Number: CC60WF
• Device Lot Number: 15308090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 11/30/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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 DELIVERY SYSTEM, INJECTOR; DUOVISC; MONARCH III CARTRIDGE D; PROVISC
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 173 KG