MAUDE Adverse Event Report: ALCON LABORATORIES, INC. AQUACOMFORT PLUS DAILIES LENSES, SOFT CONTACT, DAILY WEAR

Model Number POWER - 5.00 HI MAX ADD =2.50

Device Problems Break (1069); Component Missing (2306)

Patient Problems Visual Impairment (2138); Excessive Tear Production (2235); Discomfort (2330)

Event Date 05/02/2020

Event Type  Injury  

Event Description

Wednesday i put in my contact lenses as usual. I had opened a new package for use. Immediately after placing my left contact lense, it felt normal and i could see normally. Then after just a few minutes, it felt like i had something in my eye and it was not comfortable. I blinked several times, wondering, trying to resolve the discomfort. I could not see clearly from my left eye, wondering if the lense had fallen out. It did not feel like the lense was on my iris since nothing was in focus like normal. However i could still feel something prickly on my eye that was really uncomfortable. My eye started watering really badly and i tried to feel around for the lense. Since i could not find it and it hurt so bad, i asked my husband to look for it. He had to get a flashlight, have me open my eyelids really wide, and roll my eyes around a while. Finally he was able to find where it was and tell me where to pull out the lense. When i removed the lense, it was only part of the lense. It had a large area near the edge split out of it, and it was missing a piece that was shaped was like a pacman. My eye really hurt still and was really watering a lot. He could not see any other pieces in my eye, so i got my saline solution and started flushing out my eye. I was able to find the little piece and removed it from my eye. My eye took a while to stop watering because it had been so irritated by the broken lense and piece of lense. This happened again on saturday so i decided to report both incidences. The second incidence is in another report. Product is alcon aquacomfort plus dailies. Exp 07/2024. Lot a0603632. Power -5. 00 hi max add +2. 50. Fda safety report id# (b)(4).

Event Description

Additional information rec'd from reporter on 5/5/2020 for report # mw5094380. Today i put in my contact lenses as usual. I opened a new package for use. Immediately after placing my left contact lense, it felt normal and i could see normally. Then after just a few minutes, it felt like i had something in my eye and it was not comfortable. I blinked several times, wondering, trying to resolve the discomfort. I could not see clearly from my left eye, wondering if the lense had fallen out. It did not feel like the lense was on my iris since nothing was in focus like normal. However i could still feel something prickly on my eye that was uncomfortable. I tried to feel around for the lense and could not locate it. I asked my husband to look for it. It was able to see the contact with a flashlight and pointed me to the area to extract the lense. When i removed the lense, it was shattered in the center and the very center piece was missing. The center of the lense had cracks radiating out from the center, where the piece was missing. I discarded the faulty lense and i could still feel something in my eye. I grabbed my saline solution and started to rinse my eye out, and eventually removed the particles of lense through flushing my eyeball. This is the second time in a week that this product has broken in my eye, right after i put them in. I am placing a separate form for the other incident since it is a different date and different details. Product is alcon aquacomfort plus dailies. Exp 07/2024. Lot a0603632. Power -5. 00 hi max add +2. 50.

• Brand Name: AQUACOMFORT PLUS DAILIES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 10024963
• MDR Text Key: 189969534
• Report Number: MW5094380
• Device Sequence Number: 1
• Product Code: LPL
• 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,Followup
• Report Date: 05/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: POWER - 5.00 HI MAX ADD =2.50
• Device Lot Number: A0603632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 05/04/2020 Patient Sequence Number: 1