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

Model Number	SN6AT8
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 physician reported that following intraocular lens (iol) implantation, the lens was opacified.The iol was explanted and exchanged for same model with different diopter.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
The lens was returned in a non-company lens case.Solution was dried on the lens.The optic was torn/split/cracked and cut with multiple scratches and scrape marks on the anterior and posterior sides of the lens.The observed damage is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Associated products were not provided.It is unknown if a qualified products were used.The product investigation could not identify a root cause for the reported complaint.Other then the lens damage the lens appears clear.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided that the company lens (5.25cyl), 12.5 diopter lens implanted in 2012 was exchanged for a company lens (4.50cyl), 7.0 diopter lens.The company lens (5.25cyl), 12.5 diopter lens being exchanged in 2021 (nine years later) for a company lens (4.50cyl), 7.0 diopter lens may suggest that the replacement lens model was an improved choice for the patient's current vision needs.

• Brand Name: ACRYSOF IQ TORIC 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 ; 8175514979
• MDR Report Key: 12487400
• Report Number: 1119421-2021-01772
• Device Sequence Number: 19670431
• Product Code: MJP
• UDI-Device Identifier: 00380652277365
• UDI-Public: 00380652277365
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: SN6AT8
• Device Catalogue Number: SN6AT8.125
• Device Lot Number: 12025817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female