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 Conjunctivitis (1784); Endophthalmitis (1835); Uveitis (2122); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2021

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 physician reported that after cataract surgery by using an irrigation/aspiration (i/a) handpiece and phacoemulsification handpiece, a patient experienced severe endophthalmitis or toxic anterior segment syndrome (tass).Additional related information was requested but has not been provided to date.Additional information received indicating that a patient underwent cataract surgery with iol implantation in left eye.After 3 days of surgery the patient experienced with strong inflammation with suspicion of endophthalmitis or tass, conjunctival inflammation: 2+, cells in the anterior chamber: 3+, fibrin in the anterior chamber.Patient was treated with subconjunctival injection: glucocorticoid, other: reinforcement local corticosteroid treatment: antibiotic + corticosteroids 6 times a days; corticosteroid + antibiotic 3 times a days; fluoroquinolones + antibiotics 6 times a days.Medication was effective and patient symptoms were resolved.New information received indicating viscoelastic, balanced salt solution and procedure pak is also a suspect for the adverse event.

Manufacturer Narrative

Additional information has been 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 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: 16136352
• MDR Text Key: 307063898
• Report Number: 3002037047-2023-00005
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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 Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 04/17/2023
• 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: ADRENALINE; BETADINE 10%; INSTUMENTATON N°18; MEDICONTUR640 ADY22 DIOPTRIE; MYDRIASERT; OCULAR 5%; QUINOFREE; STERDEX; STERITRIP; TOBRADEX; XYLOCAINE GEL
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Female