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

Model Number SY60WF

Device Problem Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2022

Event Type  malfunction  

Event Description

A nurse reported during the intraocular lens implantation a defect was noticed in the center of the lens after insertion.Additional information has been requested and received stating the patient was not hospitalized for the event and no intervention was needed.The surgery was completed on the same day.Additional information received and was clarified that the lens was scratched.

Manufacturer Narrative

The lens was returned in the lens case.The carton had the word "scratched" written on it.Viscoelastic and blood were dried on the lens.The lens had been cut across the center almost into two pieces (typical of removal).The lens was cleaned with klrp for further evaluation.A large scrape mark was observed on the posterior surface near the cut area.Chipped areas were observed on the optic edge.The used returned company cartridge was evaluated.Viscoelastic was observed in the cartridge.The cartridge tip and heavy stress and a small aneurysm.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause for the observed lens damage could not be determined.A large scrape mark was observed on the posterior optic surface along with removal damage.The returned used cartridge had heavy tip stress and a small aneurysm.Top coat dye stain testing was conducted with acceptable results.The large scrape mark may indicate the lens/plunger were not in acceptable positions for advancement.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Type of Device: 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: 16045789
• MDR Text Key: 307624482
• Report Number: 1119421-2022-02721
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/24/2022

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
• Device Operator: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.225 CLAREON
• Device Lot Number: 15431359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL INJECTOR.; MONARCH II LOADING FORCEPS.; MONARCH III IOL CARTRIDGE D.; PROVISC.; UNSPECIFIED FORCEPS.; VISCOAT.
• Patient Age: 66 YR
• Patient Sex: Male