MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that they have patient's that have experienced toxic anterior segment syndrome (tass).A completed questionnaire was received indicating the patient received medical treatment in the right eye of a adrenocortical steroid injection.An antibiotic, steroid and non-steroidal were administered to the patient.This is the first of six (6) reports from this facility.
Additional Manufacturer Narrative
Corrected information has been provided in b.2.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported event.There are no other complaints in this lot.Customer and technical affairs were contacted to assist the customer with their concerns.Investigation has been completed based on current information.No further action warranted at this time.Based on our current tracking, there are no adverse trends for this reported complaint and based on these findings the residual risk remains unchanged and at an acceptable level.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11832687
• Report Number: 1119421-2021-01039
• Device Sequence Number: 4308433
• Product Code: HQL
• UDI-Device Identifier: 00380652332729
• UDI-Public: 00380652332729
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021

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: 07/28/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.230
• Device Lot Number: 15087092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 07/17/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/08/2021; 08/09/2021
• 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: BALANCED SALT SOLUTION WITH EPI; BROMDAY; CELESTONE 0.1CC; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC; INFINITI VISION SYSTEM; INVELTYS; PHENYLEPHRINE 2.5%; POLYMIXIN; PROPARACAINE; SODIUM BICARB; TROPICAMIDE 1%; BALANCED SALT SOLUTION WITH EPI; BROMDAY; CELESTONE 0.1CC; CUSTOM-PAK SURGICAL PROCEDURE PACK; DUOVISC; INFINITI VISION SYSTEM; INVELTYS; PHENYLEPHRINE 2.5%; POLYMIXIN; PROPARACAINE; SODIUM BICARB; TROPICAMIDE 1%
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 52 YR