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

Catalog Number 8065751795

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems 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, Conditions Term / Code Not Available (4581)

Event Date 06/14/2022

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 after cataract surgery patient experienced with severe endophthalmitis or toxic anterior segment syndrome with functional loss of eye.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Toxic anterior segment syndrome code was incorrectly submitted in initial report.The manufacturer internal reference number is: (b)(4).

Event 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.

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 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.

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
• 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: 15176140
• MDR Text Key: 297347088
• Report Number: 2523835-2022-00284
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00380657517954
• UDI-Public: 00380657517954
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065751795
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 09/02/2022; 12/13/2022; 02/17/2023
• Supplement Dates FDA Received: 08/30/2022; 09/29/2022; 01/10/2023; 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male