MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE SINGLE PIECE ULTRAFLOW SERIES; CATHETER, IRRIGATION

Catalog Number 8065817001

Device Problem Material Deformation (2976)

Patient Problem Capsular Bag Tear (2639)

Event Date 07/13/2021

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 customer reported that during a cataract surgery the irrigation/aspiration(i/a) tip a i/a handpiece was found to have a burr.There was no report of patient harm.Additional information has been requested.Additional information received indicated that posterior cut happened while cortical cleaning.The intraocular lens(iol) was placed to tamponade the hole in posterior capsule.There was no vitreous present.No surgical or medical intervention was required.

Manufacturer Narrative

The ultra irrigation aspiration(ia) tip was received for evaluation.A visual assessment of the returned sample found to have a dig on the tip, no burr was observed.How or when this nonconformity occurred remains inconclusive.No functional testing was able to be performed.Based on the information obtained, the root cause of the reported events cannot be determined conclusively.Manufacturer 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: SINGLE PIECE ULTRAFLOW SERIES
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12291841
• MDR Text Key: 265549144
• Report Number: 2523835-2021-00295
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00380658170011
• UDI-Public: 00380658170011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065817001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male