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

Model Number	SN6AT3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Impairment (2138); Capsular Bag Tear (2639)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A patient who is also a physician reported that, following intraocular lens (iol) implant procedure, the patient was experiencing, 'cross-hair' glare around points of light, lens with glistening.A corneal treatment was performed but that has not changed glare.Retinal evaluation reveal no pathology, also no improvement with yttrium aluminum garnet (yag).Additional information was received that, the left eye seemed to have a film over it with decreased brightness.A "start-cross" glare noted while looking at point sources of light and noted that it was similar to a photography filter he had used in the past.No abnormalities on the lens surface were noted.Lens exchange was referred noting increased risk of surgery due to open posterior capsule.
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.(b)(4).
Event or Problem Description
A patient who is also a physician reported that, following intraocular lens (iol) implant procedure, the patient was experiencing, 'cross-hair' glare around points of light, lens with glistening.A corneal treatment was performed but that has not changed glare.Retinal evaluation reveal no pathology, also no improvement with yttrium aluminum garnet (yag).Additional information was received that, the left eye seemed to have a film over it with decreased brightness.A "start-cross" glare noted while looking at point sources of light and noted that it was similar to a photography filter he had used in the past.No abnormalities on the lens surface were noted.Lens exchange was referred noting increased risk of surgery due to open posterior capsule.
Additional Manufacturer Narrative
Correction: on initial mdr the patient code of 2639 - capsular bag tear was an error.It has been removed.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received that, "star-cross¿ glare noticed while looking at point sources of light when covering his right eye.Also experienced of transient blurred vision of his left eye while working on his computer, which are relieved for a short period with increased blinking and/or refresh plus artificial tear drops use.

• 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 ; 8007579780
• MDR Report Key: 13521171
• Report Number: 1119421-2022-00252
• Device Sequence Number: 11880443
• Product Code: MJP
• UDI-Device Identifier: 00380652250016
• UDI-Public: 00380652250016
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2022

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: 10/31/2021
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.260
• Device Lot Number: 12507908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/25/2022; 04/20/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/20/2022; 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III IOL CARTRIDGE C; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male