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

Catalog Number 8065571000

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

Patient Problem Endophthalmitis (1835)

Event Date 08/13/2020

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 healthcare professional reported that a patient experienced endophthalmitis postoperatively.The patient was hospitalized and was started on ongoing antibiotic and corticosteroid treatment.Vitreous sampling was performed and the culture samples came back negative.The facility has cancelled all ophthalmic procedures since (b)(6) 2020.

Manufacturer Narrative

There was no sample returned for evaluation.The chemical lab tested a reference sample on ph and osmo and all tests are conform the specifications for the tested parameters.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.As no manufacturing related issues were identified, reference sample is conform the specifications for the tested parameters and no sample is available, a conclusive root cause could not be determined.All batches are released according to the required specifications.As no product is returned and/or insufficient product data is available, 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
• MDR Report Key: 10502405
• MDR Text Key: 205952780
• Report Number: 3002037047-2020-00023
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 8065571000
• Device Lot Number: 20A22LA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION; BVI CAPSULORHEXIS FORCEPS; CUSTOM-PAK SURGICAL PROCEDURE PACK; PHYSIOL MICROPURE HYDROPHOBE; STELLARIS; STELLARIS CASSETTE; BALANCED SALT SOLUTION; BVI CAPSULORHEXIS FORCEPS; CUSTOM-PAK SURGICAL PROCEDURE PACK; PHYSIOL MICROPURE HYDROPHOBE; STELLARIS; STELLARIS CASSETTE
• Patient Outcome(s): Hospitalization; Required Intervention