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 Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.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.Additional information has been requested.(b)(4).

Event Description

A nurse manager reported that viscoelastic product was used during a cataract with intraocular lens implantation surgery in the left eye.Postoperatively, the patient experienced possible ocular infection.Additional information has been requested.

Event Description

Additional information received clarified that due to findings by an external consultant regarding residual debris found on reusable ophthalmic devices used during procedures at the reporting facility, the reporter no longer has any suspect with any alcon product.

Manufacturer Narrative

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: 7933411
• MDR Text Key: 122628954
• Report Number: 3002037047-2018-00023
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN60WF 21.5SN: (B)(4); SN60WF 21.5SN: (B)(4)
• Patient Outcome(s): Other
• Patient Age: 80 YR