MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ULTRAFLOW II I/A HANDPIECE; CATHETER, IRRIGATION

Catalog Number 8065817801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 05/12/2021

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 physician reported that after the surgery patient experienced toxic anterior segment syndrome (tass) like endophthalmitis.The procedure details were not provided.Additional information has been requested.Additional information received indicated tass has been diagnosed and not endophthalmitis.The patient recovered using topical steroids and antibiotics.

Manufacturer Narrative

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

Event Description

Additional information received confirmed, the topical steroids and antibiotics drops are part of the normal post-operative regimen.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of tass; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ULTRAFLOW II I/A HANDPIECE
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 12258285
• MDR Text Key: 264460193
• Report Number: 2523835-2021-00275
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: K910245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2021

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: 8065817801
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 09/29/2021
• Supplement Dates FDA Received: 09/04/2021; 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION,TABLETOP; CONSTELLATION,TABLETOP
• Patient Outcome(s): Other
• Patient Age: 65 YR