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

Catalog Number 960571CO-001

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

No other complaints were reported for this lot.All batches are released according to the required specifications and all initial testing results are within specification (ph and osmo are within specifications).A complaint sample, one carton with insert and unopened sterile package with viscoat and provisc syringes, were received.The lab has retested the complaint sample: all results are conform to the specifications for the tested parameters for both viscoat and provisc (ph and osmo conform).In addition, the lab has retested the reference sample of this batch: all results are conform to the specifications for the tested parameters for both viscoat and provisc (ph and osmo conform).As the complaint sample and retain sample was conforming and all initial testing results are within specification, a conclusive root cause could not be determined for the inflammation.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse manager reported 8 patients who had inflammatory reactions after cataract extraction procedures.The site is currently investigating the possible causes of the inflammation and have found that the common factor in them all is the use of duovisc.All patients are being treated with anti-inflammatory therapy.Additional information has been requested.

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6438137
• MDR Text Key: 70972652
• Report Number: 3002037047-2017-00015
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 960571CO-001
• Device Lot Number: 16A11TA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BSS BAG 500ML
• Patient Outcome(s): Required Intervention