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

Catalog Number 160909000J

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Endophthalmitis (1835); Foreign Body In Patient (2687)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

No sample or confirmed lot number information has been received by manufacturing for evaluation.Two possible lot numbers have been received.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 viscoelastic product was used during a combination cataract and vitrectomy surgery after which the patient presented with postoperative endophthalmitis.Additional information has been requested.Additional information received further clarified that the patient symptoms first occurred two-days post operatively.Fibrin was observed on (b)(6) 2020 and the fundus could not be seen.Anterior chamber washing and vitrectomy was performed.Hypopyon was observed on (b)(6) 2020 and the fundus could not be seen.A second vitrectomy was performed.It was reported that there is a possibility of explanting the intraocular lens (iol).Bacterial cultures are being performed, but the results are not yet available.Additional information received further clarified that the same viscoelastic syringe was used for four patients.

Manufacturer Narrative

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

Manufacturer Narrative

Complaint trending was reviewed for the two potential lot codes provided, 19k04ka and 19j23ma.There were no other similar complaints found for either of the two potential lot codes outside of the related complaints.Batch records were reviewed and all testing results met specifications for both potential lot codes at the time of release.Ten unopened viscoelastic folding boxes with potential lot number 19k04ka and five unopened viscoelastic folding boxes with potential lot number 19j23ma were received as complaint samples.The chemical lab tested the ph and the osmolality of the products and the results are within specifications.Since all initial test results are conforming, no production deviations that could cause the reported defect were reported and the returned samples are conforming for the tested parameters, the complaint could not be confirmed.A root cause cannot be determined.After investigation, we can conclude that the investigated product met specifications at the time of release therefore, a specific corrective action or preventive action cannot be initiated however, further trending is performed.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOAT 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
• MDR Report Key: 10058858
• MDR Text Key: 196772737
• Report Number: 3002037047-2020-00016
• 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,Followup
• Report Date: 10/07/2020

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: 160909000J
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 09/28/2020
• Supplement Dates FDA Received: 06/01/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: HOYA VA-70AD IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR