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

Catalog Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

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

An ophthalmic surgeon reported that during a procedure the patient experienced a burn at the incision site.There was a milky release.There was a permanent occlusion.A suture was required to close the wound.The case was completed with the same system.

Manufacturer Narrative

All batches are released according to the required specifications.A lot code would be required for review of the complaint history and further evaluation.Adverse events are followed up by medical safety.No sample has been received for evaluation.A lot code would be required for evaluation.As no sample was returned and no lot number is known, a conclusive root cause could not be determined.All batches are released according to the required specifications.The manufacturer internal reference number is: (b)(4).

Event Description

After further review it was determined that it is unknown if a suture was required as previously reported.

• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7312053
• MDR Text Key: 101465020
• Report Number: 3002037047-2018-00002
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/03/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention