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 Problems Inflammation (1932); Toxicity (2333)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

All batches are released according to the required specifications.A lot code would be required for review of the complaint history and further evaluation.As no sample was returned and no manufacturing related issues were identified, a conclusive root cause could not be determined.A potential root cause of the adverse event related complaint include a solution quality issue, but this is unlikely; chemistry and microbiology data must met requirements prior to release of product.(b)(4).

Event Description

A nurse reported multiple patients presented with tass (toxic anterior segment syndrome) following phacoemulsification procedures.The patient this report represents presented with excessive inflammation (2+ cells and 1+ fibrin) in the anterior chamber on post-operative day #1.The frequency of use for the patient's steroidal drops were increased in proportion to the degree of inflammation observed.This is the sixth of thirteen reports being filed for this facility.

• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5801317
• MDR Text Key: 49753820
• Report Number: 3002037047-2016-00133
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention