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

Catalog Number	0004510129
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample has been received by manufacturing for evaluation.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 is seven of seven reports for this reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported an "outbreak" of 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 patients associated with this report of tass had a history of glaucoma.The exact procedure performed on any one patient remains unconfirmed.This file represents two out of the four patients.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in d.4, d.9, h.3, h.4, h.6 and h.10.A sample has been received.Complaint indication cannot be visually inspected.This returned product cannot confirm this complaint indication.Complaint trending reviewed for the lot code provided.Two similar complaints found.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 warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• MDR Report Key: 11718441
• Report Number: 2184002-2021-00005
• Device Sequence Number: 3765364
• Product Code: LZP
• UDI-Device Identifier: 00380651830851
• UDI-Public: 380651830851
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P890047
• 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): 07/12/2021

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: 06/30/2023
• Device Catalogue Number: 0004510129
• Device Lot Number: 028876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021; 06/22/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 04/23/2021; 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other