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); Appropriate Term/Code Not Available (3191)

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

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

This is the fourth of six reports for this reported event.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 physician reported that after intraocular lens implant surgery the patients experienced with toxic anterior segment syndrome.Additional information has been requested.Additional information received indicating a surgeon reported that an ophthalmic phacoemulsification handpiece had white specimens, 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 19 vitreous cell and floaters with no pain or erythema and no anterior chamber reaction.Upon examination of the patient, the surgeon noted aqueous cell and conjunctival inflammation.The patient was prescribed with post-operative steroid eye drops and antibiotics.No cultures were performed.The patient's symptoms have been improving without any additional treatment.

Manufacturer Narrative

The phaco handpiece was received and a visual assessment of the returned phaco handpiece revealed a dented irrigation line and strain relief damage.Additionally, the phaco handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation/aspiration lines and nose cone.The phaco handpiece was then flushed for particulates testing.The particulate sample was visually and microscopically analyzed and found to contain several blue fibers up to 1.2mm in length and a few clear fibers up to 1.9mm in length.Microscopic examination also shows a clear particle approximately 129m in length and another clear particle approximately 163¿m in length.The fibers and particles were isolated and analyzed.The analysis found the blue fiber and clear fiber to best match wypall fibers (paper).The first clear particle was found to best match poly(arylene ether sulfone).The second clear particle was found to best match ploy(diemethylsiloxane).However, the exact identity, origin and quantity of the fibers and particles remains inconclusive.A flow rate test was performed on the irrigation and aspiration lines of the phaco handpiece which found the phaco handpiece to meet product specifications.The returned phaco handpiece was connected to a calibrated vision system.The phaco handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the phaco handpiece to meet alcon specifications.Testing found the handpiece to meet functional specifications.Unrelated to the reported event, a visual assessment revealed a dented irrigation line, damaged strain relief , and nicks/scratches inside the irrigation/aspiration lines and nose cone.However, how, or when these nonconformities occurred remains inconclusive.Although the existence of foreign material was able to be confirmed, the exact identity, origin and quantity of the particles and fibers remains unknown.It should be known that handpieces are inspected during manufacturing for metal particulates.The inspection approach taken follows a statistically valid continuous sampling plan.No nonconformities were observed during manufacturing of this handpiece.The root cause of the reported event is 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: 12700459
• MDR Text Key: 278518888
• Report Number: 2028159-2021-01224
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065750469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL.; BSS PLUS STERILE INTRAOCULAR IRRIGATING SOLUTION.; CENTURION VISION SYSTEM.; DUOVISC VISCOELASTIC SYSTEM.; EPINEPHRINE.; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED.; OFLOXACIN.; POVIDONE IODINE 10%.; POVIDONE IODINE 5%.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male