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

Model Number 09424X

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Visual Impairment (2138); Visual Disturbances (2140)

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Alternative report identification number: (b)(4).Device evaluation: the solution was not returned to the manufacturing site for investigation.Therefore, the consumer's reported complaint could not be confirmed.Manufacturing record review: a review of the records was performed.The records for production process were found to be acceptable, all testing items were completed and met specifications.There was no non-conformances related to this complaint.The reported lot was deemed acceptable for release and there was no indication of a malfunction or product quality deficiency.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, a product deficiency was not determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported through a medwatch report that a consumer purchased complete multi purpose solution.The consumer brought it home, broke the seal, poured it into the contact case, and washed out their contacts.The lens case was put on the bathroom shelf.The consumer used the contact solution for several weeks and started developing sores in the right and left eyes.They went to see the eye doctor and was referred to an ophthalmologist.The ophthalmologist cultured the solution and found that it grew pseudomonas aeruginosa, an infection that is methicillin resistant.The consumer has very little to no vision in their left eye, and in the right eye it's hazy, shadowy.The consumer has been restricted by their doctor from driving and working.Consumer has been treated to hopefully restore some of their vision.The doctor stated they are going to have a permanent scar across the pupil and likely will not regain a lot of sight in the left eye.Although that is not yet certain.No further information was provided.Medications prescribed: tobramycin eye drops, vancomycin eye drops, prednisone steroid eye drops.

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 SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8012217
• MDR Text Key: 125276988
• Report Number: 3004178847-2018-00011
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 30827444000615
• UDI-Public: (01)30827444000615(17)190618(10)ZC06600
• Combination Product (y/n): Y
• PMA/PMN Number: K014202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2019
• Device Model Number: 09424X
• Device Lot Number: ZC06600
• 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): Required Intervention; Disability