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 Codes	Conjunctivitis (1784); Endophthalmitis (1835); Uveitis (2122); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/17/2021
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 physician reported that after cataract surgery by using an irrigation/aspiration (i/a) handpiece and phacoemulsification handpiece, a patient experienced severe endophthalmitis or toxic anterior segment syndrome (tass).Additional related information was requested but has not been provided to date.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received indicating that a patient underwent cataract surgery with iol implantation in left eye.After 3 days of surgery the patient experienced with strong inflammation with suspicion of endophthalmitis or tass, conjunctival inflammation: 2+, cells in the anterior chamber: 3+, fibrin in the anterior chamber.Patient was treated with subconjunctival injection: glucocorticoid, other: reinforcement local corticosteroid treatment: antibiotic + corticosteroids 6 times a days; corticosteroid + antibiotic 3 times a days; fluoroquinolones + antibiotics 6 times a days.Medication was effective and patient symptoms were resolved.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
New information received indicating viscoelastic, balanced salt solution and procedure pak is also a suspect for the adverse event.

• 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: 15176301
• Report Number: 2523835-2022-00286
• Device Sequence Number: 1856324
• Product Code: GBX
• UDI-Device Identifier: 00380657517954
• UDI-Public: 00380657517954
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K910245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/11/2023
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 8065751795
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 09/02/2022; 12/13/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/29/2022; 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADRENALINE; BETADINE 10%; BSS + ADRENALINE; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; DUOVISC; DUOVISC VISCOELASTIC SYSTEM; INSTUMENTATON BOX N°18; MEDICONTUR 640 ADY 22 DIOPTRIES; MYDRIASERT; OCULAR 5%; PROCEDURE PACK; QUINOFREE; STERDEX; STERITRIP; TOBRADEX; UNSPECIFIED HP; XYLOCAINE GEL
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Female