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

Catalog Number ASKU

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Eye Burn (2523)

Event Date 02/01/2020

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

Event Description

A surgeon reported a patient experienced a corneal burn during a cataract extraction procedure.The patient had a small anterior chamber, therefore it was necessary to use a greater amount of ophthalmic viscoelastic (ovd) to inflate the anterior chamber.The phacoemulsification (phaco) tip filled with the ovd upon insertion of the tip into the eye.The ovd was crystallized upon activation of the handpiece and the phaco tip clogged.Without cooling the burn was immediate.The occlusion alarm from the system did sound and was heard by the surgeon, but he did not realize the severity until the burn was noted.The tip was removed form the eye, rinsed and unclogged and the case was completed.A suture was required to close the wound.On post operative day one the patient presented with endothelial detachment and corneal folds.Additional information has been requested and received.Additional information received indicated that this ovd is not the usual ovd used by this surgeon.

Manufacturer Narrative

A supplemental medical device report (smdr) # 01 is being filed to correct the g.4 date on the prior filed supplemental report.Incorrect date of 02/27/2020 is being corrected to 02/26/2020.  a sample was not provided for evaluation; therefore the product cannot be confirmed.A lot code was not reported, therefore lot specific complaint history cannot be performed.No further evaluation or root cause analysis can be conducted at this time.A photo was reviewed; however the events reported cannot be confirmed based on the photo.No root cause could be determined as a sample was not provided for evaluation and a lot code was not reported.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOAT 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: 9872072
• MDR Text Key: 184696458
• Report Number: 3002037047-2020-00010
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION OZIL HP; CENTURION VISION SYSTEM; CENTURION OZIL HP; CENTURION VISION SYSTEM
• Patient Outcome(s): Required Intervention