MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60AT
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
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.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following implantation of an intraocular lens (iol), a scratch was observed under a microscope.The lens was cut and removed during the initial procedure and surgery was completed with no issues to the patient.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned.The customer indicated the use of a non-qualified cartridge.The customer indicated the use of a viscoelastic, which is not qualified for cartridge use.The root cause is most likely related to a failure to follow the dfu.The account used an unqualified lens/cartridge combination.The customer indicated the use of a non-qualified cartridge the alleged lens model is only qualified for use in the other company cartridges.The use of non-qualified combinations may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens was cut in half, typical of insertion and removal from the eye, and adhered to each other by solution.The lens was cleaned with lphse.One haptic is broken in the gusset area.Scratches are observed on the optic.A deep scratch is observed on the surface of the haptic.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the reported complaint may be related to a failure to follow the ifu.The ifu instructs that a 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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11869868
• Report Number: 1119421-2021-01076
• Device Sequence Number: 11567044
• Product Code: HQL
• UDI-Device Identifier: 00380652555890
• UDI-Public: 00380652555890
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2021

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: 10/31/2024
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.245
• Device Lot Number: 12760885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 07/22/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/07/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYALU OVD; MONARCH CARTRIDGE D