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 07/16/2021

Event Type  Injury  

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

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 phacoemulsification (phaco) 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 toxic anterior segment syndrome (tass).These findings continue to validate the need to follow the recommendations detailed in the dfus, association of perioperative registered nurses (aorn) recommended practices, and the american society of cataract and refractive surgery (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.There were six (6) phaco handpieces (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.The reviews for complaints reported against this lot/batch/serial number were performed.There were no similar complaints were reported for the product lot/batch/serial under investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.Phaco hp (1) - the phaco handpiece was received and a visual assessment of the returned sample revealed a dented irrigation line.Additionally, the phaco handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation and aspiration lines and nose cone.The handpiece was then flushed for particulates testing.The particulate sample was visually and microscopically analyzed and found to contain a clear particle approximately 300 m in length.Microscopic examination also shows numerous clear and dark fibers up to 1mm and 1.7mm in length respectively.The clear particle, clear fibers and dark fibers were isolated and analyzed.The analysis found the clear particle¿s best match to be polypropylene.The clear fiber and dark fiber were found to best match fibers (paper) and cotton respectively.However, the exact origin and quantity of the fibers 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 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 functional specifications.Testing found the handpiece to meet functional specifications.Unrelated to the reported event, a visual assessment revealed a dented irrigation line as well as nicks/scratches inside the irrigation/aspiration lines and nose cone.Phaco hp (2) - was received and a visual assessment of the returned sample revealed a dented irrigation line.Additionally, the phaco handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation and 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 numerous blue fibers and clear fibers up to 1.3mm and 1.4mm in length respectively.Microscopic examination also shows a clear particle approximately 645 m in length.A blue fiber, a clear fiber and the clear particle were isolated and analyzed.The analysis found the blue fiber to best match cotton.The clear fiber was found to best match fibers (paper).The clear particle was found to best match polypropylene.However, the exact origin and quantity of the fibers 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 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 specifications.Although the existence of foreign material was able to be confirmed, the exact identity, origin and quantity of the particles and fibers remains unknown.Phaco hp (3) - was received and a visual assessment of the returned sample revealed a dented irrigation line.Additionally, the handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation and 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 numerous blue fibers and clear fibers up to 544mm and 851mm in length respectively.Microscopic examination also shows a clear particle approximately 261 m in length.A blue fiber, a clear fiber and the clear particle were isolated and analyzed.The analysis found the blue fiber and clear fiber to best match cotton.The clear particle was found to best match poly(tetrafluoroethylene).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 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 as well as nicks/scratches inside the irrigation/aspiration lines and nose cone.However, how, or when these nonconformities occurred remains inconclusive.Phaco hp (4) - 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 129 m 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 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 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 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.Phaco hp (5) - was received and a visual assessment of the returned sample revealed a dented irrigation line.Additionally, the phaco handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation/aspiration lines and nose cone as well as discoloration inside the aspiration line.The phaco handpiece was then flushed for particulates testing.The sample was visually and microscopically analyzed and found to contain numerous clear fibers and blue fibers up to 900 m and 1.6mm in length respectively.Microscopic examination also shows numerous black particles and reflective particles up to 150 m and 80 m in length respectively.The fibers and particles were isolated and analyzed.The analysis found the blue fiber and clear fiber to best match cotton.Analysis of the black particles identified carbon (c), oxygen (o), sodium (na), magnesium (mg), aluminum (al), silicon (si), sulfur (s), potassium (k), calcium (ca), titanium (ti), chromium (cr), and iron (fe).However, the exact identity of the black particles is unknown.Analysis of the reflective particles identified carbon (c), aluminum (al), titanium (ti), and vanadium (v).The presence of these elements along with the visual characteristics suggests the reflective particles are a titanium alloy.However, the exact 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 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 specifications.Although the existence of foreign material was able to be confirmed, the exact identity, origin and quantity of the particles and fibers remains unknown.Phaco hp (6) - was received and a visual assessment of the returned sample revealed a dented irrigation line.Additionally, the phaco handpiece was inspected under a microscope which revealed nicks/scratches inside the irrigation/aspiration lines and nose cone as well as discoloration inside the aspiration line.The phaco handpiece was then flushed for particulates testing.The particulate sample was visually and microscopically analyzed and found to contain a brown particle approximately 210 m in length, an opaque particle approximately 200mm in length, a clear particle approximately 203 m in length, blue a few blue fibers up to 272 m in length, and a few reflective particles up to 211 m in length.The fibers and particles were isolated and analyzed.The analysis found the brown particle to best match chipboard.The opaque particle was found to best match delrin.The clear particle was found to best match protein.The blue fiber was found to best match cotton.Analysis of the reflective particles identified carbon (c), oxygen (o), silicon (si), chromium (cr), manganese (mn), iron (fe), and nickel (ni).The presence of these elements along with the visual characteristics suggests the reflective particle is most likely a stainless steel.However, the exact origin and quantity of the particles and fibers 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 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 specifications.Testing found the phaco handpiece to meet functional specifications.Unrelated to the reported event, a visual assessment revealed a dented irrigation line, nicks/scratches inside the irrigation/aspiration lines and nose cone and discoloration inside the aspiration line.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.Pertaining to all six (6) phaco hps: how, or when these 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 handpieces are inspected during manufacturing for metal particulates.The inspection approach taken follows a statistically valid continuous sampling plan, per military standard.No nonconformities were observed during manufacturing of this handpieces.The root cause of the reported ¿tass, aqueous cells, medical intervention, and corneal edema¿ is inconclusive.The root cause of the reported ¿abnormalities in hps¿ is also inconclusive.The 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: 12785377
• MDR Text Key: 280571583
• Report Number: 2028159-2021-01321
• 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

• Date FDA Received: 11/10/2021
• 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
• Date Manufacturer Received: 03/01/2022
• 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: EPINEPHRINE; INTRACAMERAL LIDOCAINE; OFLOXACIN; POVIDONE IODINE 10%
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female