MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number	8065183085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported a patient experienced toxic anterior segment syndrome (tass) in the right eye following a cataract extraction procedure.The patient presented 1 day post op with aqueous cell and fibrin.Cultures were not taken.The patient required an increase in the frequency of non-steroidal anti-inflammatory drug (nsaid) medication.The patient is reported to be improving with topical medication adjustment.This is the first report of three for this patient.
Additional Manufacturer Narrative
This report represents patient two of three from this facility.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.(b)(4).
Additional Manufacturer Narrative
No lot code or sample provided.No further evaluation or root cause analysis can be conducted at this time.No root cause could be determined as no sample or lot code was provided for analysis.No action is warranted the manufacturer internal reference number is: (b)(4).

• Brand Name: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer (Section G): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12760704
• Report Number: 3002037047-2021-00044
• Device Sequence Number: 3439615
• Product Code: LZP
• UDI-Device Identifier: 00380651830851
• UDI-Public: 00380651830851
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P890047
• 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): 12/23/2021

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: 8065183085
• Device Lot Number: ASKU
• 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: 11/29/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CENTURION VISION SYSTEM; CUSTOM-PAK SURGICAL PROCEDURE PACK; OFLOXACIN DROPS; POVIDONE IODINE 10%; RAYONE ASPHERIC IOL 18.5D; VANCOMYCIN ADDED TO BSS BAG
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male