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

Catalog Number ASKU

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Autoimmune Reaction (1733)

Event Date 04/03/2019

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.(b)(4).

Event Description

A physician reported a patient experienced an immune response following a cataract extraction procedure with intraocular lens implant.The patient was treated with cortisone.Additional information has been requested but not received.

Manufacturer Narrative

Additional information has been provided in a.1., b.3., b.5.And h.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received indicating the patient presented to post operative appointment the next day with edema and conjunctival hemorrhage.The anterior chamber was rinsed and topical treatment was required, there was a temporary change in the patient's visual acuity.The patient was given a post operative preventative treatment of steroid and antibiotic for fifteen days.

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.In the previous twelve months there were no similar complaints.No customer sample was returned.A review of the batch record and raw materials found no gluten.Root cause cannot be determined based on current available data and no sample received.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: 8703300
• MDR Text Key: 148146178
• Report Number: 3002037047-2019-00006
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR