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

Catalog Number	8065817001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2523835-2021-00295
• Device Sequence Number: 3807144
• Product Code: GBX
• UDI-Device Identifier: 00380658170011
• UDI-Public: 00380658170011
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K910245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male