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 Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Malfunction
Event or Problem Description
An administrator reported following an intraocular lens (iol) implant procedure, the patient experienced star bursts and visual disturbances.The lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for the explant was there was a scratch on the intraocular lens that was affecting patient vision.Additional information was requested, but further no information was available.
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).
Additional Manufacturer Narrative
The associated product information was not provided.It is unknown if qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.The sample was not returned for an evaluation.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The initial report description indicated that there were starbursts and visual disturbances.The clinical reason given was that there was a scratch on the intraocular lens that was affecting the patient's visual acuity.The associated product information was not provided.It is unknown if qualified associated products were used.The instructions for use (ifu) instructs that a qualified company 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.Follow up was provided that the surgeon did not explant the lens.The lens was adjusted in the eye and the symptoms resolved.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating explant was not performed as panned previously.The surgeon was able to adjust the lens and left it in place.Patient's symptoms were resolved.

• 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: 15697163
• Report Number: 1119421-2022-02302
• Device Sequence Number: 15299942
• Product Code: HQL
• UDI-Device Identifier: 00380652335775
• UDI-Public: 00380652335775
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 15383061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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 Sex: Unknown