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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN SALES, LLC REFRESH CONTACTS, CONTACT LENS COMFORT DROPS ; ACCESSORIES, SOFT LENS PRODUCTS
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ALLERGAN SALES, LLC REFRESH CONTACTS, CONTACT LENS COMFORT DROPS ; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Lot Number 08743
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem Discharge (2225)
Event Type  malfunction  
Event Description
Because my contact lenses were bothering me, i purchased two (2) over-the-counter products made by allergan, inc., (b)(4) u.S.A.Refresh contacts, contact lens comfort drops, 0.4 fl oz (12 ml) sterile; and refresh optive gel drops lubricant eye gel, extended therapy 0.33 fl oz (10 ml) sterile.However, the refresh contacts, contact lens comfort drops packaging does not include any "drug facts" itemization of the percentages of its ingredients (as does their other refresh optive gel drops product); the packaging merely lists "contents" of the product.I would have better determined the origin of the discharge coming from my eyes that resulted several hours after using both products if i could have known the strength of the contents of the refresh contacts, contact lens comfort drops.Reason for use: contact lenses were irritating and sticking to my eyes.Thank you.
 
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Brand Name
REFRESH CONTACTS, CONTACT LENS COMFORT DROPS
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALLERGAN SALES, LLC
MDR Report Key9213850
MDR Text Key163168317
Report NumberMW5090493
Device Sequence Number1
Product Code LPN
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/15/2021
Device Lot Number08743
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
Patient Weight72
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