MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION SURGICAL, INC. COMPLETE; SOLUTIONS

Model Number 09424X

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Alternative report number: (b)(4).Date of manufacture: unknown, as lot number was not provided.Unknown, no information was provided.The device has not been returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device can not be performed.As a lot number was not provided.If there is any further relevant information provided or obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson vision surgical, inc.Has been submitted.

Event Description

It was reported via a social media post, that a caller from an ophthalmology clinic was reporting an experience with a patient who was using the complete multi purpose solution with their contacts and tested (b)(6) for a bacteria.Information was not provided as to what exactly tested positive, if it was the patient, the contacts or the solution.No further information was provided.

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: COMPLETE
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON VISION SURGICAL, INC.; santa ana CA
• MDR Report Key: 7733728
• MDR Text Key: 115522747
• Report Number: 3004178847-2018-00009
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K014202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 09424X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other