MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number 900545DKN-001/0

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

Patient Problem Endophthalmitis (1835)

Event Date 12/02/2022

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 a patient experienced endophthalmitis after using an ophthalmic visco surgical device in a cataract procedure.The patient was given with non-steroidal anti-inflammatory drugs and corticosteroids and performed vitrectomy.Surgery was completed on the same day.The current condition of the patient is not known and getting treated at the hospital.This report is for the seventh patient (os) involved in the event.

Event Description

Genetic sequencing found the strain of s.Epidermidis present in patient cultures was not identical to the bacteria isolated during initial testing of the product by a third-party hospital.Results of additional microbiological testing of the product by the third-party hospital were negative for growth.Based on their testing, the hospital concluded there is no to reason to believe that the product is the source of the postoperative infections.The first test result wherein s.Epidermidis was isolated from the product is believed to be the result of contamination during the testing this report is for the left eye of the seventh patient involved in the event bilateral endophthalmitis. the events for this patient are recorded in alcon ref.(b)(4) (left eye)  and (b)(4) (right eye).

Manufacturer Narrative

Complaint trending was reviewed for the lot code provided.There were (b)(4) similar complaints found (all complaints are from 2 sites in denmark).  no sample was returned for evaluation to date.  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.   there were no confirmed out-of-specification stability deviations and no unusual trends were observed for the stability results of the stability batches tested during the review period of this annual product quality review (apqr).Environmental control: the following items were checked as part of the investigation by environmental control: * total number of environmental monitoring samples collected during filling: 1) viables: incorporation room (07/040): 28/07/2022 ¿ 29/07/2022.26 samples for active air, passive air and surfaces, 34 samples for personnel (gloves and gown).Filling (room 07/179) 29/07/2022 ¿ 02/08/2022.50 samples for active air, passive air and surfaces, 75 sample for personnel (gloves and gown).2) non-viable particles: incorporation and filling: continuous sampling in class a and b background a.* trends analysis for the filling suite: no negative trends identified for both the incorporation room and the filling room.Conclusion: there were no deviations for environmental control.All results were conforming.In addition, there were no negative trends.Aseptic processes: all relevant aseptic processes and equipment are in requalified status.Release & sterilization cycles: discovisc batch vd822a was released without any deviations.All related qc-testing (including sterility, lal, particles, animal testing) results were conforming.The batch was sterilized in cycle 03115016 (sterigenics petit rechain ¿ st7) in three 3 carts; all carts of the cycle were conforming.In the same cycle, carts of two other batches were sterilized, and both were also free from deviations.As no manufacturing related issues were identified, , and no complaint sample was received, no manufacturing related root cause was identified.All batches are released according to the required specifications.Based on the complaint information and the investigation results, we can conclude that the disposition of the product remains unchanged.As no manufacturing related issues were identified, no manufacturing related root cause was identified.Therefore, no action is initiated.Manufacturer will continue to monitor for evidence of adverse trending of reported events and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
• 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: 16022985
• MDR Text Key: 305893616
• Report Number: 3002037047-2022-00107
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup
• Report Date: 02/04/2023

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: 900545DKN-001/0
• Device Lot Number: VD822A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 01/30/2023
• Supplement Dates FDA Received: 01/25/2023; 02/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS; CUSTOM-PAK; HALCION; IOL DELIVERY SYSTEM,; KNIFE; LIDOCAINE; METHOXIDRIN; MONARCH CARTRIDGE; OXYBUPROCAINE; POVIDONE IODINE; SODIUM CHLORIDE; SPERSADEX; THEA APOKRAM; TROPICAMIDE; VOLTABAK
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male