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	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.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, the surgeon noted a scratch on the iol through the microscope.The iol was immediately explanted and replaced with a new lens to complete the procedure with no patient harm.Additional information requested.
Additional Manufacturer Narrative
Evaluation summary: the reporter indicated the used of a qualified cartridge, with a handpiece, and a non-qualified viscoelastic, the root cause is may be likely related to a failure to follow the directions for use.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
• MDR Report Key: 11437056
• Report Number: 1119421-2021-00508
• Device Sequence Number: 4369955
• Product Code: HQL
• UDI-Device Identifier: 00380652335737
• UDI-Public: 00380652335737
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 05/12/2025
• Device Model Number: SA6AT3
• Device Lot Number: 15069845
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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: AMVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Patient Age: 62 YR