MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPACT INTUITIV CONSOLE

Model Number	SCP680300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system was evaluated by a field service engineer.The field service found no issues with the unit.A field service checklist was performed.The unit complied with all factory settings.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
The surgeon reported that during cataract surgery on (b)(6) 2019, once he applied the phaco tip to the patient's left eye he immediately saw a white plume appear and removed the tip.The patient required a single figure 8 suture following the corneal burn.The surgeon reported that the event may have been due to physician technique, but he could not confirm this.On (b)(6) 2019, a secondary procedure was performed on the left eye by applying an additional single figure 8 suture over the incision.The patient is still healing.This report is for the compact intuitiv phaco system.An additional report is being submitted for the 21 gauge laminar phaco tip.
Additional Manufacturer Narrative
Correction: in initial report, the manufacturing date was reported as 8/22/2017.The correct date is 7/11/2017.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa: 010215.

• Brand Name: COMPACT INTUITIV CONSOLE
• Common Device Name: COMPACT INTUITIV
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9337408
• Report Number: 3006695864-2019-00905
• Device Sequence Number: 2243351
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/12/2019; 10/25/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/18/2019; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHACO TIP; PHACO TIP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005