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

Model Number	SV25T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.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 an intraocular lens iol) implant procedure, the patient experienced blurred vision, residual astigmatism, and hyperopia.The iol was exchanged in a secondary procedure.Additional information has been requested.
Event or Problem Description
Additional information was provided by a nurse that the iol was exchanged for a company iol with increased toricity and power.This would indicate an attempt to adjust or fine tune the refractive outcome.There is no reported defect or fault with the lens.
Additional Manufacturer Narrative
Corrected and additional information was provided in a.2., a.3., b.2., b.5., b.6., b.7., d.10., and e.4.Summary: no supplemental report will be required as the additional information provided indicated that the iol was exchanged in an attempt to adjust or fine tune the refractive outcome trying to achieve a desired target.Had this information been received prior to submission of the initial medical device report the reported event would not have been reportable.The manufacturer internal reference number is:(b)(4).

• Brand Name: ACRYSOF IQ RESTOR 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: 11784589
• Report Number: 1119421-2021-00965
• Device Sequence Number: 4043197
• Product Code: MJP
• UDI-Device Identifier: 00380652311243
• UDI-Public: 00380652311243
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 03/31/2022
• Device Model Number: SV25T3
• Device Catalogue Number: SV25T3U215
• Device Lot Number: 12527612
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR