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

Catalog Number 960569AUS001

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

Patient Problems Endophthalmitis (1835); Hypopyon (1913)

Event Date 08/07/2020

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 a patient experienced endophthalmitis.Additional information has been requested and received indicating the patient experienced inflammatory response endophthalmitis following a vitrectomy procedure.The patient presented post operative day one with conjunctival inflammation, aqueous cell, hypopyon and fibrin in the right eye.Cultures were performed and the patient required intravitreal injections of antibiotics.Steroid and antibiotic eye drops were also prescribed.The patient's symptoms have resolved.This is one of several reports for this facility.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information has been provided in h.6.And h.10.Complaint trending not performed as no lot code was reported.There was no sample returned for evaluation.The complaint condition could not be confirmed.A root cause could not be determined due to no lot code or sample for evaluation.The manufacturer internal reference number is: 2020-64689.

Manufacturer Narrative

Corrected information has been provided in h.1.- "summary report".The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: PROVISC 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: 10926993
• MDR Text Key: 218914190
• Report Number: 3002037047-2020-00026
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• PMA/PMN Number: P890047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 960569AUS001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AKREOS AO 60 LENS; ALCON BSS; CONSTELLATION VIT PAK; POVIDONE IODINE; AKREOS AO 60 LENS; ALCON BSS; CONSTELLATION VIT PAK; POVIDONE IODINE
• Patient Outcome(s): Other; Required Intervention