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

Model Number	SA60AT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A health professional reported that a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.The patient presented post-operatively with no signs of symptoms.Upon examination of the patient, the surgeon noted 4+ aqueous cell and 2+ aqueous fibrin.The patient was prescribed with post-operative antibiotic and steroid eye drops.No cultures were performed.The patient's symptoms have been resolving without any additional treatment.This is the fourth of four reports for this event.
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 report represent the third patient of three from this facility.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned for evaluation.The product history records were reviewed and documentation indicated the product met release criteria.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 12763831
• Report Number: 1119421-2021-02070
• Device Sequence Number: 3170792
• Product Code: HQL
• UDI-Device Identifier: 00380652555784
• UDI-Public: 00380652555784
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 06/05/2026
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.190
• Device Lot Number: 15212914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSS STERILE IRRIGATING SOLUTION; BSS WITH VANCOMYCIN; CENTURION VISION SYSTEM; CUSTOM-PAK SURGICAL PROCEDURE PACK; INTRACAMERAL LIDOCAINE; LIDOCAINE GEL; OFLOXACIN; POVIDONE IODINE 10%; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; SURGICAL PRODUCT, UNSPECIFIED
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female