MAUDE Adverse Event Report: LIFECORE BIOMEDICAL, LLC DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number	0004980036
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.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 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
Complaint trending was reviewed for the lot code provided.Two similar complaints were found.Returned product cannot confirm this complaint indication.The complaint condition could not be confirmed as the indicated problem cannot be visually inspected with the returned sample.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.Based on the investigation, the lack of additional complaints for this lot, the returned sample evaluation, and the acceptable batch record review, no further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• MDR Report Key: 11760201
• Report Number: 2184002-2021-00010
• Device Sequence Number: 17301921
• Product Code: LZP
• UDI-Device Identifier: 00380651831506
• UDI-Public: 00380651831506
• 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
• Report Date (Section B): 07/02/2021

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: 04/30/2023
• Device Catalogue Number: 0004980036
• Device Lot Number: 028665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 07/02/2021
• 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.; CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Other