MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the records related to this equipment that included labeling, manual, trending, and risk documentation reviews was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigation's associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.
Event or Problem Description
It was reported that a foreign matter, which looked like a piece of metal 2-3mm long, entered into patient¿s eye at the beginning of phaco procedure during surgery.The foreign matter was immediately removed from patient¿s eye.There was no patient injury.
Additional Manufacturer Narrative
A video assessment of the foreign matter was performed.Per the video evaluation, it was observed that during the phacoemulsification a foreign particle that appears to be metallic was introduced in the eye and that the foreign particle was withdrawn from the intraocular space.However, based on review of the video as well as all information provided, the nature of the particle could not be confirmed.The origin, nature, and potential clinical impact of the observed phenomena could not be determined from a video assessment.An external laboratory analysis was performed.The lab analysis indicated the metal was a titanium alloy.This is used in the manufacturing of handpieces (titanium metal fabrication) and phaco tips used with handpieces (titanium coating).An engineering evaluation of the identified material was performed, potential sources of titanium flakes.The internal fluid paths of handpiece are made of solid titanium.No coatings.Engineer is not aware of any likely places for titanium to flake off.The phaco handpiece and phaco tips are made from titanium.If during phaco another instrument contacts a phaco tip while power is being applied there could be a potential of flakes being generated.If customer uses a reusable tip beyond 20 uses, there is risk of flakes.Product evaluation was not performed for this incident.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13728535
• Report Number: 3012236936-2022-00597
• Device Sequence Number: 4710515
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132(17)991231(10)E212900
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• Device Lot Number: E212900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHACO TIP, ST01-S (JMR CORPORATION), WRENCH.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian