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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR

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ALCON RESEARCH, LLC DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92003729
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Corneal Abrasion (1789); Pain (1994); Visual Disturbances (2140); Burning Sensation (2146); Corneal Infiltrates (2231); Microcysts, Epithelial (2232); Excessive Tear Production (2235)
Event Date 05/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The complaint sample has not returned for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
 
Event Description
It was reported by a medical adviser that the patient experienced serious adverse events while wearing the complaint contact lenses. Medical records dated (b)(6) 2019 reported that on (b)(6) 2019, the patient felt as if something was in her right eye (od) and felt stinging sensation which went away after 15 minutes. The patient continued to use contact lenses daily and on (b)(6) 2019, the patient experienced stinging sensation again which got worse and by the end of the day, the consumer experienced pain and the contact lenses were removed three hours later. The patient visited the ophthalmologist a day after and the patient was diagnosed with corneal erosion with infiltration around. The patient was prescribed with ciprofloxacin eye drops five times daily. The pain was not resolved and the patient's visual acuity became cloudy like milk-glass. Slit lamp evaluation revealed there were microcysts on the corneal surface (od) and there was staining abrasion in the center, three mm in diameter. The base and the upper nasal quadrant was heavily infiltrated (white in color) while the other parts were less infiltrated. There was stromal infiltration around, there was radial descemet folds and the aequous humor could not be evaluated. The pupil was mid-sized, with good light reaction, and with no synechiae. The lens surface was clear, however, the deeper part cannot be evaluated. Treatment included levofloxacin one drop every hour, tobramycin/dexamethasone every three hours, cicloplegicedol every three hours and the patient was advised for a follow up visit for control the day after. Medical records dated (b)(6) 2019 reported that the pain had decreased but the visual acuity did not improve. There were microcysts on the corneal surface, there was demarcation on the infiltrated zone but still white and corneal erosion still existed. The cornea was still cloudy but was less than the previous evening, there was less descemet folds and the pupil was dilated but the dilatation was not maximal. Treatment included gentamicin 80 mg/ml subconjunctival injection (1. 8ml), levofloxacin one drop every hour, tobramycin/dexamethasone every three hours and cicloplegicedol every three hours and the patient was advised for a follow up visit for control on (b)(6) 2019. Upon the medical control on (b)(6) 2019, it was revealed that there was demarcation, the corneal tissue was more clear and there were no microcysts. Treatment included tobramycin/dexamethasone, cicloplegicedol and 2x500 mg levofloxacin pills. It was reported that the visual acuity did not yet improve and the patient was scheduled for medical control on (b)(6) 2019. Additional information was received on (b)(6) 2019 via email. It was reported that the patient visited the eye care professional (ecp) on (b)(6) 2019 which revealed that lacrimation and the conjunctival suffusion were resolving, the center of the cornea was white, the opacity was dense with sharp edges and there was a lack of epithelium above it. It was added that around the cornea/stroma was clear, there were no descemet folds on the back surface and the pupil was dilated. Therapy included subconjunctival dexamethasone which was given at the time of control, levofloxacin one drop every two hours, tobramycin/dexamethasone one drop every three hours, cicloplegicedol five times and dexpanthenol. The patient was scheduled for a follow up visit the next day and on (b)(6) 2019. Additional information was received on (b)(6) 2019 via email. It was reported that the result of the microbial test was positive for escherichia coli.
 
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Brand NameDAILIES TOTAL 1
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer (Section G)
ALCON RESEARCH, LLC
11440 johns creek parkway
duluth GA 30097
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8665195
MDR Text Key146910927
Report Number1065835-2019-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberCBV92003729
Device Lot NumberA5053967
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/03/2019 Patient Sequence Number: 1
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