MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM DUOVISC VISCOELASTIC SYSTEM; AID, SURGICAL, VISCOELASTIC

Catalog Number	0005710057
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported an "outbreak" of toxic anterior segment syndrome (tass) at their facility.In a follow up with the customer, it was reported that there were four patients who presented with tass following ocular surgery.There were two surgeon's involved.All four of the tass cases also had glaucoma and three of the patient's had combined cataract and glaucoma procedure.It is unknown at this time which surgery was performed on which patient.This file represents one of the four patients.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
As a complaint sample one folding box, one leaflet and one unopened blister was received.The chemical lab has tested the returned sample both syringes) and all results are conform the specifications for the tested parameters.Our lab has tested the retain samples of the viscoat and provisc ibc lot and all results conform the specifications for the tested parameters.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.As no manufacturing related issues were identified, retain samples conform the specifications and the results of the returned sample are conform the specifications, the complaint cannot be confirmed.All batches are released according to the required specifications.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.The manufacturer internal reference number is: (b)(4).

• Brand Name: DUOVISC VISCOELASTIC SYSTEM
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• MDR Report Key: 11728338
• Report Number: 3002037047-2021-00010
• Device Sequence Number: 3894627
• Product Code: LZP
• UDI-Device Identifier: 00380651999077
• UDI-Public: 380651999077
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P840064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2021

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 Catalogue Number: 0005710057
• Device Lot Number: 20F30IA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 08/31/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/03/2021; 09/10/2021
• 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: CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other