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

Catalog Number ASKU

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

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 06/06/2019

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 customer reported that during a cataract extraction procedure a foreign body was observed.The foreign has created discomfort for the patient as it is located in the middle of the visual field.An attempt was made to extract the foreign body.It is unknown if this attempt was made during the original procedure or if the patient returned for another procedure on a different day.Additional information has been requested but not received.

Manufacturer Narrative

No customer sample was returned.All testing results met specifications for this lot code at the time of release.No deviations were identified during the manufacturing of the batch that would have contributed to this complaint.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: 8821810
• MDR Text Key: 152048359
• Report Number: 3002037047-2019-00008
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: ASKU
• Device Lot Number: 19A21JA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAUSCH & LOMB PHACO EMULSIFICATOR PAK; BAUSCH & LOMB PHACO EMULSIFICATOR PAK
• Patient Outcome(s): Required Intervention