MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065751763

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 05/17/2018

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 two patients experienced inflammation reaction post surgery.These patients required additional intervention.The symptoms are improving.Hospitalization was not required.The surgeon is suspecting this maybe caused by how the handpieces are cleaned and not sterilization procedure.Additional information has been requested.This is the second of two reports being filed from this facility.

Manufacturer Narrative

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

Event Description

A customer reported that two patients experienced inflammation reaction post surgery.These patients required additional intervention.The symptoms are improving.Hospitalization was not required.The surgeon is suspecting this maybe caused by how the handpieces are cleaned and not sterilization procedure.Additional information has been requested.This is the second of three reports being filed from this facility.A completed questionnaire has been received indicating the patient presented with increased iop and corneal edema at one day post operative visit.The corneal edema remains unresolved.Topical treatment was required for the corneal edema.Corneal edema remains unresolved.

Manufacturer Narrative

This is an (b)(6) year-old female patient who was scheduled for cataract surgery in the left eye (os).Three patients were reported to have tass post-operatively.This is the second of three patients reported.The customer stated ¿they have concluded that due to the lack of training of the operating staff in the cleaning and sterilization, the handpieces and the (i/a) have not followed an adequate procedure in the cleaning, (not in sterilization).¿ this patient is has a previous medical history of anxiety and aortic stenosis.Preoperative data was listed as: uncorrected visual acuity (va) (b)(6) 2018 20/60 (0.3),best corrected va (b)(6) 2018 20/60 (0.3), and the intraocular pressure (iop) 11mmhg.Postoperative data was listed as: uncorrected visual acuity (va) (b)(6) 2018 20/40 (0.5), iop 15mmhg (with treatment), and the best corrected va (b)(6) 2018 20/40 (0.5).This patient did not have cultures taken per the additional information obtained.The most common causes of toxic anterior segment syndrome (tass) are identified as follows in order of prevalence: inadequate flushing of phaco, irrigation/aspiration handpieces and cannulated equipment, use of enzymatic cleaners and detergents, use of reusable cannulas, inadequate cleaning of instruments, use of preserved epinephrine, reuse of single use devices, use of tap water with no sterile water final rinse, inadequate personnel or trays to allow proper preparation of instruments, no immediate cleaning allowing ophthalmic viscoelastic device (ovd) and surgical solutions to dry on instruments, use of preserved medicines in the eye, reuse of tubing for flushing, latex bulbs for irrigation, not training, no terminal sterilization, instruments stored on towels, touching of iol or patient contact areas of instruments with gloved hands, off-label use of lidocaine gel, poor instrument maintenance, autoclave residue, rust, particulates, lint, use of powdered gloves, additives added to balanced salt solution against directions for use (dfu) , improper use of prep solutions, detergents and cleaners, failure to follow manufacturer¿s directions for use, including no air flush, use of unapproved enzymatic cleaners, use of postoperative ointment in clear corneal cases, povidone-iodine placed in the eye at the end of procedures, incorrect concentration of detergents and enzymatic cleaners.The phacoemulsification systems are closed systems.They are operated with a sterile single use consumable cassette which is designed to isolate the patient fluid path from the console itself.Any surgical instrumentation that would come into contact with the patient would be cleaned and autoclaved by the user prior to surgery, per standard industry practices and company directions for use (dfu).The proper cleaning and sterilization of ophthalmic surgical instruments can help prevent the occurrence of tass.These findings continue to validate the need to follow the recommendations detailed in the dfus, aorn recommended practices, and the ascrs tass task force guidance document.There is no evidence that the design or manufacturing of the system or phaco handpiece contributed to the reported event.No further information was able to be obtained from this customer.However, the first handpiece was returned for evaluation.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The handpiece was manufactured on june 19, 2015.Based on qa assessment, the product met specifications at the time of release.The handpiece was received for evaluation.A visual assessment of the returned sample fond no visual nonconformity.The handpiece was flushed for metal particulates testing.The sample was analyzed at fort worth and found to have metallic particles up to 36 microns.The metallic particles were identified to have titanium; however, the exact origin and quantity of the metallic particles remains inconclusive.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet specifications.The handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications it was found that the handpiece met specifications.Therefore, the root cause of the reported event cannot be determined conclusively.One used single piece irrigation/aspiration (i/a) threaded handpiece was returned for evaluation for the report of endophthalmitis.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.The handpiece was manufactured in january 2015.A visual inspection of the handpiece was performed and was deemed nonconforming.There are dents around the front adapter edges from its use in placement and removal of tips onto the handpiece.This nonconformance is unrelated to the tass issue.All other areas of the handpiece are visually acceptable.All reusable handpieces are 100% visually inspected, functionally tested, and cleaned during the manufacturing process.The manufacturing facility does not do any reprocessing of any complaint samples.Based on the age of the handpiece the complaint issue does not point to a manufacturing issue.The information in the complaint file indicates a conclusion was determined that the complaint issue was due to the lack of training of the operating staff in the cleaning and sterilization of devices.No further information was able to be obtained from this customer.However, the second handpiece was returned for evaluation.The handpiece was manufactured on november 4, 2014.Based on qa assessment, the product met specifications at the time of release.The handpiece was received for evaluation.Was received for evaluation.A visual assessment of the returned sample fond no visual nonconformity.The handpiece was flushed for metal particulates testing.The sample was analyzed and found to have metallic particles up to 35 microns.The metallic particles were identified to have titanium.However, the exact origin and quantity of the metallic particles remains inconclusive.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet specifications.The handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specification.The exact origin and quantity of the metallic particles remains inconclusive.However, it was found that the handpiece met specifications.Therefore, the root cause of the reported event cannot be determined conclusively.No further information was able to be obtained from this customer.However, the third handpiece was returned for evaluation.The handpiece was manufactured on may 4, 2015.Based on qa assessment, the product met specifications at the time of release.The handpiece was received for evaluation.A visual assessment of the returned sample fond no visual nonconformity.The handpiece was flushed for metal particulates testing.The sample was analyzed at fort worth and found to have metallic particles up to 36 microns.The metallic particles were identified to have titanium.However, the exact origin and quantity of the metallic particles remains inconclusive.A flow rate test was performed on the irrigation and aspiration lines of the handpiece which found the handpiece to meet specifications.The handpiece was connected to a calibrated system.The handpiece tuned successfully and completed a five minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications.The exact origin and quantity of the metallic particles remains inconclusive.However, it was found that the handpiece met specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7577879
• MDR Text Key: 110350793
• Report Number: 2028159-2018-01171
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

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: 8065751763
• Other Device ID Number: 380657517633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/08/2018; 09/26/2018
• Supplement Dates FDA Received: 06/15/2018; 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSS PLUS WITH EPI; CENTURION HANDPIECE; MIRTAZEPINE; MONARCH CARTRIDGE; OMEPRAZOLE; PAROXETINE; PROVISC; ROXUVASTATINE; SN60WF +19.0 IOL; TORASEMIDE; ULTRAFLOW SP-SINGLE PIECE; UNSPECIFIED HANDPIECE; CENTURION HANDPIECE; ULTRAFLOW SP-SINGLE PIECE; UNSPECIFIED HANDPIECE
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR