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

Catalog Number 8065750469

Device Problems Material Discolored (1170); Particulates (1451); Pitted (1460)

Patient Problems Vitreous Floaters (1866); Inflammation (1932); Uveitis (2122); Vitritis (2181); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2021

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 surgeon reported that an ophthalmic phacoemulsification handpiece had white ¿specs¿, discoloration in the lumens, and potential pitting during a cataract surgery.The patient experienced toxic anterior segment syndrome (tass) post-operatively.The patient presented post-operative day two with floaters, no pain or erythema.Upon examination of the patient, the surgeon noted aqueous cell and conjunctival inflammation.The patient required an increase steroid eye drops and antibiotics by mouth.No cultures were performed.The patient's symptoms have been improving without any additional treatment.

Manufacturer Narrative

Phacoemulsification handpiece (hp) returned for evaluation.A phaco handpiece manufacturing device history record (dhr) reviews were performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.Phacoemulsification hp nonconformities occurred remains inconclusive.Although the existence of foreign materials were able to be confirmed, the exact identity, origin and quantity of the particles and fibers remains unknown.It should be known that handpiece are inspected during manufacturing for metal particulates.The root cause of the reported ¿tass (toxic anterior segment syndrome), aqueous cells, medical intervention, and corneal edema¿ is inconclusive.The root cause of the reported ¿abnormalities in hp is also inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate the manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL 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: 12773851
• MDR Text Key: 280520942
• Report Number: 2028159-2021-01310
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657504695
• UDI-Public: 00380657504695
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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: 8065750469
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACRYSOF TORIC ASPHERIC IOL.; BSS EPINEPHRINE.; OFLOXACIN.; POVIDONE IODINE 10%.; POVIDONE IODINE 5%.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female