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

Model Number	SN6AT8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Hyphema (1911); Inflammation (1932); Intraocular Pressure Increased (1937); Itching Sensation (1943); Blurred Vision (2137); Visual Impairment (2138); Dizziness (2194)
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 facility representative reported that, following intraocular lens implant procedure, the patent was unable to see and was feeling dizzy.The lens was exchanged in a secondary procedure.Additional information was received that, 1 day post op patient had ocular itching.Vision was very blurry and foggy.Due to increased inflammation difluprednate qday drop started until next appointment.1 week post-op, the patient was having mild corneal bullous change superior which may be causing some visual blurring - will be discontinuing difluprednate as it may be increasing iop and corneal edema.Mild corneal bullous change superior are improved since stopping difluprednate.Iop is improved but borderline od s/p hydrus -inferior microphyphema continued - not much change compared to prior visit.Developed hyphema.Continue prednisolone qid and taper weekly.The lens was exchanged and patient is doing well post-operatively.

• 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: 14699056
• Report Number: 1119421-2022-01285
• Device Sequence Number: 5262447
• Product Code: MJP
• UDI-Device Identifier: 00380652278058
• UDI-Public: 00380652278058
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/15/2022

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: 04/30/2022
• Device Model Number: SN6AT8
• Device Catalogue Number: SN6AT8U210
• Device Lot Number: 12543095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Male