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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CIBA VISION GMBH DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR

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CIBA VISION GMBH DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number N1137518
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chemosis (1775); Corneal Scar (1793); Corneal Ulcer (1796); Edema (1820); Erythema (1840); Foreign Body Sensation in Eye (1869); Hyperemia (1904); Hypopyon (1913); Pain (1994); Loss of Vision (2139); Discharge (2225); No Code Available (3191)
Event Date 06/05/2017
Event Type  Injury  
Manufacturer Narrative
The complaint product was returned for evaluation and was found to meet manufacturing specifications. An update to the initial investigation was performed; no impact was identified. The root cause could not be determined. The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information was received via e-mail from the reporter on (b)(6) 2017. It was indicated that the patient was still being treated with unspecified eye drops. The reporter confirmed that it would not be known as to whether or not the patient sustained permanent vision loss for another ten months.
 
Manufacturer Narrative
(b)(4). The actual complaint product was not returned for evaluation. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint. The root cause could not be determined. (b)(4).
 
Event Description
As initially reported by the patient's family member, on (b)(6) 2017, a male patient experienced corneal ulcer in his left eye (os). Patient was treated with an antibiotic eye drop every hour. It was reported that the patient was being followed by an eye care provider on a daily basis. Additional information was received on 06/16/2017 via questionnaire completed by eye care professional (ecp). The date of onset was reported as (b)(6) 2017. Physical examination findings were positive for a large central corneal ulcer, injection/hyperaemia, conjunctival chemosis, eye edema/erythema, epithelial defect/loss, stromal thinning, and hypopyon/anterior chamber reaction; corneal scarring was also noted. Subjectively, the patient experienced eye pain, foreign body sensation, vision loss, and discharge. The patient also experienced , eyelid edema, injection/hyperaemia, erythema, anterior chamber reaction, stromal thinning, epithelial loss and conjunctival chemosis. The patient was prescribed levofloxacin to use in the os from (b)(6) 2017; based on culture and sensitivity results from the corneal scraping, the patient was switched to ciprofloxacin and gentamycin to use in the left eye on an hourly basis on (b)(6) 2017. It was noted that the event had not yet resolved. Additional information has been requested but not yet received.
 
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Brand NameDAILIES TOTAL 1 MULTIFOCAL
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM D-63868
Manufacturer (Section G)
CIBA VISION GMBH
postfach, industriering 1
grosswallstadt D-638 68
GM D-63868
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key6691661
MDR Text Key110207043
Report Number9610813-2017-00017
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Lot NumberN1137518
Other Device ID Number000000000010110193-701502545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/06/2017 Patient Sequence Number: 1
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