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

Model Number	690880
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity- information requested but not available at the time of this report.Serial number requested but is unknown at the time of this report udi #: partial number provided as product serial number was requested but is unknown at the time of this report.Device manufacture date: unknown, as the serial number was requested but is unknown at the time of this report.Device evaluation was performed by the field service engineer (fse) who visited the site after the reported event.The fse found no issue with handpiece as it passed and met specifications.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
During a cataract procedure a corneal burn occurred in the patient's left eye.The burn required sutures and wound glue.The doctor was able to complete the procedure and at the time of this report there is no information on the patient expected outcome.

• 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: 15514123
• Report Number: 3012236936-2022-02492
• Device Sequence Number: 12242401
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 690880
• Device Catalogue Number: 690880
• 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: 08/31/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: VERITAS SN (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male