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	Macular Edema (1822); Visual Disturbances (2140)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.Each lens is subjected to a 100% assessment of the power (sphere/cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that after the implantation of the intraocular lens (iol) to correct for 3.25d of cylinder the patient still had 3.5d of cylinder in his refraction.Cystoid macular edema (cme) was noted postoperatively.Additional information was reported by a physician that the visual acuity (20/20) was corrected but the refractive cylinder still remains.The lens did not correct the astigmatism and the patient had cystoid macular edema in the operated eye.
Additional Manufacturer Narrative
Not enough information was provided by the reporter for further investigation.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 12199433
• Report Number: 1119421-2021-01414
• Device Sequence Number: 13783721
• Product Code: MJP
• UDI-Device Identifier: 00380652277952
• UDI-Public: 00380652277952
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 02/28/2022
• Device Model Number: SN6AT8
• Device Catalogue Number: SN6AT8U160
• Device Lot Number: 12533206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC; MONARCH III CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR