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	Uveitis (2122); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	09/30/2021
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 report represent the third patient of three from this facility.The manufacturer internal reference number is: (b)(4).
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 second of four reports for this event.
Additional Manufacturer Narrative
There was no sample returned for evaluation.The complaint condition could not be confirmed.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.Review of the batch record indicates the product meets specification.No manufacturing assignable root cause could be determined.There is no impact to safety, quality, or efficacy of the product.Since the root cause is likely not related to the manufacturing process and the report does not indicate a trend, no further actions are recommended at this time.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: 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: 12763809
• Report Number: 3002037047-2021-00045
• Device Sequence Number: 14239151
• 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): 01/27/2022

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: 02/29/2024
• Device Catalogue Number: 8065183085
• Device Lot Number: 029018
• 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: 01/10/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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: ACRYSOF SINGLEPIECE IOL.; BSS STERILE IRRIGATING SOLUTION.; BSS WITH VANCOMYCIN.; CENTURION VISION SYSTEM.; CUSTOM-PAK SURGICAL PROCEDURE PACK.; INTRACAMERAL LIDOCAINE.; LIDOCAINE GEL.; OFLOXACIN.; POVIDONE IODINE 10%.; SURGICAL PRODUCT, UNSPECIFIED.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female