MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number ASKU

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

Patient Problems Conjunctivitis (1784); Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Blurred Vision (2137); Fibrosis (3167); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/08/2023

Event Type  Injury  

Event Description

A customer reported that a patient was seen in clinic complaining of eye pain, blurry vision and floaters.The patient was diagnosed with endophthalmitis.The patient was treated with antibiotics and base salt solution and steroid.The patient's vision improved after the treatment.

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).

Manufacturer Narrative

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

Event Description

A nurse reported that after postoperative day 14 of cataract surgery with ophthalmic handpiece, intraocular lens, phacoemulsification tip, viscoelastic device and consumable, a 68 years old female patient experienced with endophthalmitis in left eye with symptoms of eye pain, blurry vision, floater, conjunctival inflammation was <1+, aqueous cell was 3+, aqueous fibrin was present with hypopyon.Patient was treated with intravitreal tap and antibiotics, corticosteroids medications.Culture results revealed no bacterial growth.Current patient condition was unknown.This is the report of patient 1 of 4.

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17050061
• MDR Text Key: 316404763
• Report Number: 2028159-2023-00782
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 06/15/2023
• 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: BSS STERILE IRRIGATING SOLUTION; CEFTADAZIME; CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; CUSTOM-PAK SURGICAL PROCEDURE PACK; DEXAMETHASONE; DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE; VANCOMYCIN
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female