MAUDE Adverse Event Report: ALCON DUOVISC; AID, SURGICAL, VISCOELASTIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 12/13/2016

Event Type  Injury  

Event Description

Tass pt presented with 4+ cells 1 day post op treated with meds.

• Brand Name: DUOVISC
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON
• MDR Report Key: 6293432
• MDR Text Key: 66334464
• Report Number: MW5067580
• Device Sequence Number: 1
• Product Code: LZP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BETADINE 5% BY ALCON; CENTURION PHACO MACHINE USED-BSS 500 ML DUOVISC; COMPOUNDER DILATING DROPS BY KB LABS
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR