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

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	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer year 2015.The account reported that the corneal burn event was a result of a new operating room technician selecting the default settings instead of selecting the surgeon¿s program settings.The clinic is reporting this adverse event only and did not request or require field service or clinical support.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 extraction procedure, a corneal burn occurred in the patient¿s operative eye.A suture was required to close the incision.The procedure was completed.It was reported the corneal burn event was a result of a new operating room technician selecting the default settings instead of selecting the surgeon¿s program settings.
Additional Manufacturer Narrative
In initial report, the manufacturer year was only provided, however the full date is 09/16/2015.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: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8425545
• Report Number: 3006695864-2019-00216
• Device Sequence Number: 11305490
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K060372
• 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): 11/10/2020
• 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: 02/21/2019
• Supplement Date Received by Manufacturer: 03/22/2019; 10/25/2020
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/10/2019; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005