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

Model Number	SA6AT4
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned to the manufacturing site.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported an unexpected outcome following a toric intraocular lens (iol) implantation.The surgeon believes it is possible that the lens model power was incorrectly labeled on the lens box.The surgeon plans to explant the iol.Additional information has been requested and received that the lens exchange was performed with another lens.Patient symptoms were improved.
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is cut from one edge across the lens and stops just before the opposite edge.Deep scratches are observed, on both the anterior and posterior sides of the lens.Small cracks are observed, on the optic.Marks are observed, that are in the shape of a surgical instrument used to grasp the lens.Power and resolution testing could not be conducted, due to extensive damage.Product history records were reviewed, and the documentation indicated, the product met release criteria.Associated products were not provided.It is unknown, if qualified products were used.The product investigation could not identify, a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution, during the manufacturing process in order to determine, acceptability per the lens model and diopter/cylinder.The power and resolution of the returned lens could not be re-evaluated, due to the optic damage.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: 12098825
• Report Number: 1119421-2021-01295
• Device Sequence Number: 14517763
• Product Code: HQL
• UDI-Device Identifier: 00380652336239
• UDI-Public: 00380652336239
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: SA6AT4
• Device Lot Number: 12595787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention