MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM DUOVISC VISCOELASTIC SYSTEM; AID, SURGICAL, VISCOELASTIC

Lot Number ASKU

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

Patient Problems Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Pain (1994); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/28/2023

Event Type  Injury  

Event Description

A healthcare professional reported that after cataract surgery in the right eye (od), the patient experienced floaters, endophthalmitis (positive for staphylococcus), pain, decrease visual acuity (va), pain, aqueous cells (present) and fibrin (present).The patient received dexamethasone, vancomycin and ceftazidime (od) for the events.The patient current condition was ongoing.The patient was under continuous monitoring.

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

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.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.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).

Event Description

Additional informed received and indicated that the patient's visual acuity were od - 20/40 and os - 20/60.

• Brand Name: DUOVISC VISCOELASTIC SYSTEM
• Type of Device: 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: 17668684
• MDR Text Key: 322470965
• Report Number: 3002037047-2023-00030
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• 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%; BETADINE5% TOPICAL; BSS SOLUTION; DEXA/VANCO/CEFTAZIDIME; MOXIFLOXACIN0.1%; OFLOXACIN0.3%TID; PREDNISOLONE1%TID; TROPICAM/PHENYL2.5%,PROPARA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male