MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPLETE MULTI-PURPOSE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ZC06600

Device Problems Break (1069); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Pain (1994); Swelling (2091); Loss of Vision (2139)

Event Date 06/14/2018

Event Type  Injury  

Event Description

In (b)(6) 2018 i purchased a contact solution from (b)(6) called "complete multi purpose solution" made by abbott laboratories/abbott medical optics, inc., lot # zc06600, expiration date of 06/18/2019.I brought it home and broke the seal and poured it into my contact case and washed out my contacts and put it on the shelf in my bathroom.I used the contact solution for several weeks and started developing sores in my right and left eye and went to see the eye dr and was referred to an ophthalmologist, dr (b)(6).Dr (b)(6) cultured the solution on (b)(6) 2018 and found that it grew pseudomonas aeruginosa, an infection that is methicillin resistant.I have very little to no vision in my left eye and in my right eye, i see hazy, shadowy.I have been restricted from driving and working by my eye doctor.I am treating with dr (b)(6) to hopefully restore some of my vision but dr (b)(6) has said that i am going to have a permanent scar across my pupil, and likely will not regain a lot of my sight in the left eye, although that is not yet certain.Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018.To clean and disinfect contact lenses.

• Brand Name: COMPLETE MULTI-PURPOSE SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 7624662
• MDR Text Key: 112025589
• Report Number: MW5077967
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/18/2019
• Device Lot Number: ZC06600
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 45 YR
• Patient Weight: 84