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 Bacterial Infection (1735); Conjunctivitis (1784); Endophthalmitis (1835); Visual Impairment (2138); Fibrosis (3167); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/10/2023

Event Type  Injury  

Event Description

A nurse reported that after 14 days of cataract surgery, patient experienced endophthalmitis in right eye vision decrease, positive for p.Acne.It was treated with intravitreal tap procedure and antibiotics and steroid medications.Current patient condition was unknown.Before surgery patient's bcva was 20/50 -2 and after surgery 20/cf 1 ft.Patient had conjunctival inflammation was <2+, aqueous cell was 3+, aqueous fibrin was present, hypopyon was absent.Intravitreal tap and injection of vancomycin, ceftazadime and dexamethasone used as a intervention for the events.It was unknown whether the intervention for the events effective or not.No sutures used, no surgical complications.

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).

Manufacturer Narrative

Additional information is provided in sections h.6 and h.10.All batches are released according to the required specifications.A lot code would be required for review of the complaint history and the batch documentation.Adverse events are followed-up by medical safety.No product returned for evaluation.Inconclusive, no product returned: as no product returned and all initial testing results are within specification a conclusive root cause could not be determined.All batches are released according to the required specifications.None - no product returned/insufficient information: as no product is returned, the complaint could not be verified and therefore no capa is initiated.However further trending is performed.The manufacturer internal reference number is: (b)(4).

• 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: 17133624
• MDR Text Key: 317209116
• Report Number: 2184002-2023-00002
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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
• 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
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CEFTADAZIME; DEXAMETHASONE; PREDNISOLONE; VANCOMYCIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female