MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SA6AT3
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
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 non health care professional reported during implantation of an intraocular lens (iol) the scratch on the lens.There was no patient contact.Procedure was completed and product is available for return.Additional information was requested and received scratch was noted upon implanting the lens.Surgeon was able to remove lens and replace with same model.No patient harm.
Additional Manufacturer Narrative
Only the lens case lid, extra label set, and carton were returned.The lens was not returned for evaluation.The account indicated, the use of a qualified associated cartridge and handpiece.The viscoelastic indicated, is not qualified for the lens/cartridge combination used.The file indicated, the use of a qualified associated cartridge and handpiece.The root cause for the reported complaint may be related to a failure to follow the ifu(instructions for use).The viscoelastic indicated, is not qualified for the lens/company product combination used.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 product has not been received to evaluate.File will be reopened when product is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15644877
• Report Number: 1119421-2022-02235
• Device Sequence Number: 14975929
• Product Code: HQL
• UDI-Device Identifier: 00380652335768
• UDI-Public: 00380652335768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• 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): 11/30/2022

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 Model Number: SA6AT3
• Device Lot Number: 15294066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: MONARCH III IOL INJECTOR; MONARCH III IOL CARTRIDGE D; PROVISC
• Patient Sex: Unknown