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

Catalog Number	8065751795
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	09/01/2024
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that the patient experienced endophthalmitis.Details of procedure was not reported.Additional details had been requested and none received till date.
Additional Manufacturer Narrative
Corrected information is provided in sections b.5.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A customer reported that following the use of phacoemulsification handpieces (hps) and irrigation/aspiration (i/a) hps, patients experienced endophthalmitis.Procedure details and current patient conditions were not reported.Additional information has been requested but has not been received to date.
Additional Manufacturer Narrative
One opened ultraflow ii handpiece was returned for the report of a contamination concern.The returned sample was visually inspected and found to be non-conforming with a white and brownish, yellow foreign material observed on the inside walls on the irrigation part of the handpiece.The particle analysis found the foreign material to most closely match poly methyl methacrylate (pmma).A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A photo attached to the parent complaint was reviewed by the investigation site.The photo shows an ozil handpiece.The reported issue was not confirmed from the photo review.The particle analysis found the foreign material to most closely match poly methyl methacrylate (pmma).Pmma is not is not a material that is used in the manufacturing process of the ultraflow handpiece.How and when the pmma got in it cannot be determined from this evaluation.The ultraflow handpiece dfu (direction for use) provides detailed instructions for proper cleaning and inspection of product prior to use.The root cause of contamination inside the irrigation part of the handpiece is from improper handling.This handpiece has been in service for approximately seven years.No action has been taken as it appears that the observed contamination was due to user handling.All handpieces are 100% visually inspected prior to being released from the manufacturing facility.The ultraflow handpiece dfu provides detailed instructions for proper cleaning and inspection of product prior to use.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ULTRAFLOW II I/A HANDPIECE
• 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: 20540972
• Report Number: 2523835-2024-02260
• Device Sequence Number: 12816799
• Product Code: GBX
• UDI-Device Identifier: 00380657517954
• UDI-Public: 00380657517954
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K910245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2005
• Device Catalogue Number: 8065751795
• Device Lot Number: 532441M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/27/2024; 02/14/2025
• Initial Report FDA Received Date: 10/27/2024
• Supplement Report FDA Received Date: 11/21/2024; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2000
• 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 Sex: Unknown