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

Model Number 09424X

Device Problem Device Emits Odor (1425)

Patient Problems Conjunctivitis (1784); Pain (1994); Red Eye(s) (2038)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Alternative report number: (b)(4).Device evaluation: the product was returned to the manufacturing site for investigation.Microbiological and chemical test were performed per requirements.All testing results met product specifications.The consumer's reported complaint could not be verified.A search on complaints was conducted.Results revealed two complaints for this product lot number.Manufacturing record review: the records for production process were found to be acceptable, all testing items were completed and met specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, along with warning for the proper use and handling of the product.Based on the results of the investigation, a product deficiency was not identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The consumer reported that she smelled a sulphur odor after soaking her contact lens overnight using complete multi purpose solution.After soaking the lens, she inserted the lens and her right eye become red and painful.Patient mentioned that she went to her doctor and may have conjunctivitis.She will be returning to her doctor for a follow up visit.In follow-up communication, it was learned that the consumer received prescription eye drops (dosage twice a day) from her general practitioner to address her eye issue.Her eye is currently not as red, some days she still feels pain.Patient also confirmed the first day of use was (b)(6) 2018, and that she noticed the odor upon opening the bottle.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 SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8272849
• MDR Text Key: 133932579
• Report Number: 3004178847-2019-00001
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 20827444000656
• UDI-Public: (01)20827444000656(17)190922(10)ZC07588
• 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
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2019
• Device Model Number: 09424X
• Device Lot Number: ZC07588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2018
• 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