MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.This second of two reports for this reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported that a patient experienced toxic anterior segment syndrome (tass) after use of a viscoelastic product in an intraocular lens implantation surgery.Additional information has been requested.This file represents patient 2 of 2 from this facility.Additional information received indicated that the surgeon also suspected the intraocular lens (iol) also as a cause of event.Additional information received indicated that tass with diffuse corneal edema in a cataract surgery in the left eye was observed.
Additional Manufacturer Narrative
The product was not returned for investigation.We are unable to confirm the reported complaint.Based on the results from the product, batch and sterilisation history record, the products met release criteria.All product and batch history records are quality reviewed prior to product release.There have been no other complaints for this reported lot.Investigation has been completed based on current information.No further action is warranted at this time.Based on our trend analysis, there are no adverse trends identified for this complaint and based on these findings the residual risk remains at an acceptable level.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 LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 12257191
• Report Number: 9612169-2021-00161
• Device Sequence Number: 4861215
• Product Code: MJP
• UDI-Device Identifier: 00380652274319
• UDI-Public: 00380652274319
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 06/30/2024
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.190
• Device Lot Number: 21250456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/31/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR