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 Unspecified Infection (1930); Inflammation (1932)

Event Date 07/01/2020

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 customer reported four patients experienced postoperative infections, suspected endophthalmitis.The viscoelastic and a competitor intraocular lens (iol) were two similarities found in all four cases.Additional information has been requested but not received.

Manufacturer Narrative

Additional information has been provided in b.5 and h.6.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received.Lab tests were run on the four patients and no pathogens were detected in either the anterior or posterior segments, so the surgeon suspects toxic anterior segment syndrome (tass) and not endophthalmitis as first suspected.Contamination of the materials used has been ruled out.Additional information is not expected.

Manufacturer Narrative

A specific lot code was not provided for this complaint; therefore, a lot specific complaint history cannot be reviewed.A two-year review of similar events for the reported product resulted in zero similar complaints.The sample for this complaint has not been received from the customer and the status of the sample is unknown.Each batch is subject to documentation review and must meet acceptance criteria prior to release to the market.The root cause of the reported event cannot be determined.Specific failure modes and/or mechanisms cannot be determined without the lot code or returned complaint sample.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.There are no adverse trends associated with the reported event.Alcon will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 10277762
• MDR Text Key: 205300954
• Report Number: 3002037047-2020-00018
• 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,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other