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

Model Number 08772X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Red Eye(s) (2038); Blurred Vision (2137); No Code Available (3191)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation: the product was returned to the manufacturing site for evaluation.Chemical testing was performed on the retuned sample, all test results were within product specification, no product deficiency was identified.Manufacturing records review: all the records for production process were found to be acceptable, all testing items were completed and met specifications.Complaint data was trended in previous 12 months by the reported lot number: ze07664.The search results showed only the objective complaint was reported in the previous 12 months.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported that she experienced blurred vision and redness while wearing her contact lenses yesterday, (b)(6) 2020.Consumer used complete solution to clean her contact lenses before applying them to the eyes.At the time of calling in her issue, her symptoms were not improving.The consumer reports she saw a physician who stated her cornea was damaged by the either the contact lenses or the solution.The physician prescribed sodium hyaluronate eye drops, one drop, every 2 hours; levofloxacin eye drops once every 4 hours, one drop, each time; calf blood deproteinized extract eye gel 3 times one drop.The consumer is an experienced contact lens wearer and rubs and rinses her contacts.She replaces her lenses fortnightly (every two weeks).She is a smoker and has not had lasik surgery.Through follow-up it was learned the consumer went to the hospital and was examined for her eye condition.The physician stated her eyes were getting better but still needs to apply the medication.The consumer reports that she is still sensitive to light and could not watch the screen for a long time.The consumer stated that she has an appointment with her physician to double check her eye condition next week.No further information was provided.

• Brand Name: COMPLETE
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; 4th ave; hz econ/tech develop. zone; hangzhou 31001 8; CN 310018
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10633177
• MDR Text Key: 212509705
• Report Number: 3004178847-2020-00021
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)220906(10)ZE07664
• Combination Product (y/n): Y
• PMA/PMN Number: K040839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2022
• Device Model Number: 08772X
• Device Lot Number: ZE07664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2020
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention