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

Catalog Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Visual Impairment (2138)

Event Date 10/16/2023

Event Type  Injury  

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 Description

A nurse reported that the patient had endophthalmitis and best corrected visual acuity decreased in the right eye of a 71 year old male patient after cataract surgery.The patient current condition was improving.It was undetermined which product caused or contributed to the reported event, therefore all manufacturer products used during the initial procedure have been captured.

Manufacturer Narrative

No sample has been received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.Every lot is verified that all required tests have been performed and all acceptance criteria were met at time of release.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.There are no adverse trends associated with the reported event.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.Investigation has been completed based on current information.Based on the investigational findings the in-process controls and product acceptance criteria continue to be acceptable.Complaint trends are monitored for evidence of adverse trending of reported events and take further action, as appropriate.The manufacturer internal reference number is:.

• Brand Name: DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• Manufacturer (Section G): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18192353
• MDR Text Key: 328808532
• Report Number: 2184002-2023-00006
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BETADINE 5%.; BSS 500 ML.
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male