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	Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Uveitis (2122); Loss of Vision (2139); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/14/2022
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 after cataract surgery patient experienced with severe endophthalmitis or toxic anterior segment syndrome with functional loss of eye.Additional information has been requested.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of post-cataract severe endophthalmitis with functional loss of eye; 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).
Event or Problem Description
New information received indicating viscoelastic, balanced salt solution and intraocular lens also a suspect for the adverse event.Current patient condition was non-resolved loss of total function with probable purulent melting of the eye.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Toxic anterior segment syndrome code was incorrectly submitted in initial report.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
New information received indicating a patient underwent cataract surgery with iol implantation in right eye with medical history of non-insulin dependent diabetes (well-balanced).After nine days of surgery the patient experienced with severe endophthalmitis with loss of function of the eye, conjunctival inflammation: 3+, cells in the anterior chamber: 3+, fibrin in the anterior chamber, hypopyon with signs and symptoms of pain, edema of the upper eyelid, cyclitic membrane preventing examination of the vitreous.Patient was admitted in hospital treated with subconjunctival injection, intravitreous injection of antibiotics, glucocorticoid injection, intravitreous injection of glucocorticoid, steroid in subconjunctival form.Administered medication was not effective and patient symptoms were not resolved and purulent melting of the eye.This event leads to total loss of visual function and risk of purulent melting.
Additional Manufacturer Narrative
A sample was not received at the manufacturing site for evaluation for the report of post-cataract severe endophthalmitis with functional loss of eye; 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
• 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: 15176140
• Report Number: 2523835-2022-00284
• Device Sequence Number: 11226613
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/17/2023
• 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; 02/17/2023
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/29/2022; 01/10/2023; 03/17/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 INTRAVITREOUS INJ. OF ANTIBIOTICS; ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; ADRENALINE; BETADINE 10%; BSS + ADRENALINE; BSS SOLUTION; BSS STERILE IRRIGATING SOLUTION; CELESTENE IN SUBCONJUNCTIVAL; CENTURION SURGICAL PAK; CENTURION SURGICAL PROCEDURE PAK; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; DUOVISC; DUOVISC VISCOELASTIC SYSTEM; DUOVISC VISCOELASTIC SYSTEM; I.V INJECTION OF DEXAMETHASONE; INSTRUMENTATION BOX #3; MYDRIASERT; OCULAR 5%; PROCEDURE PACK; SOLUMEDROL BOLUS INJECTION; STERITRIP; TOBRADEX; TORIC EXTENDED VISION IOL; UNSPECIFIED IA HANDPIECE; VIVITY TORIC LENS; VIVITY TORIC LENS; XYLOCAINE GEL
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male