MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE PLUS WITH HYDRAGLYDE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Date 01/01/2017

Event Type  No Answer Provided  

Event Description

While visiting my optometrist, they had samples of contact lens products in boxes on the coffee-table in the waiting area.I was told i could take them with me on my way out.I took a box of clear care plus with hydraglyde that had a travel size lens solution with a lens case in the box.Later when i was packing to leave for a trip, i had already packed my current lens case, but decided to use the travel size bottle in the sample pack for convenience.I pulled out the bottle but did not look at the case since i already had one.When i was on camping trip, i used the solution to store my lenses overnight.I glanced at the bottle and skimmed the directions since there was fine print next to the red cap.I saw that lenses should be soaked for at least 6 hours to allow the solution to neutralize and that lenses should not be rinsed with this solution.I soaked the lenses for longer than 6 hours and did not rinse, however, i missed that the solution could only be used with the proprietary case and assumed that any case would be fine.When i inserted the right lens the next morning, i experienced horrible pain in my right eye.I removed the lens as quickly as i could, although it was difficult to open my eye enough to remove the lens.I washed my eye out with water from our camping water jug for several minutes, but i did not time exactly how long i rinsed.The pain and discomfort lasted for 2 days, improved for 3 days, then i had a headache behind the affected eye for another day one week from the original incident.I experienced no loss of vision or altered vision.I used high doses of ibuprofen to control the pain and inflammation.I discarded those lens and used new ones the next time.Medication administered to or used by the pt: no.When and how was error discovered: horrible burning pain in my eye when i inserted the lens.Pt counseling provided: unk.Reporter's recommendations: i believe this product should be prescription only or at least kept behind the counter at clinics and pharmacies to allow the opportunity for a verbal warning on how to properly use this product.I had not realized how essential it is to use only the proprietary case in order to avoid injury.There is a high risk of this product being used improperly due to its similar appearance to non-toxic solutions.Pts are at risk for serious eye injury from using this solution.I would not have used this product at all if i had been warned that it was not interchangeable with other lens solutions.(b)(4).

• Brand Name: CLEAR CARE PLUS WITH HYDRAGLYDE
• Type of Device: CLEAR CARE PLUS WITH HYDRAGLYDE
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 6950996
• MDR Text Key: 89694956
• Report Number: MW5072759
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1