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U.S. Department of Health and Human Services

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

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CIBA VISION GMBH DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92004051
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994)
Event Date 03/21/2018
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 initially reported on (b)(6) 2018 that a consumer developed a sub-conjunctival hemorrhage on her left eye on (b)(6) 2018. It was reported that the left contact lens was "bothering" to the consumer. It was reported that redness on the temporal part of the sclera was observed with absence of pain. It was reported that the consumer experienced a ¿very painful¿ left eye upon waking up on (b)(6) 2018 and it was also noted that the eye redness was more diffused. The eye care professional (ecp) diagnosed the consumer with corneal ulcer. The consumer was prescribed with besifloxacin ophthalmic suspension (0. 6%), one drop four times a day (qid); preservative-free lubricant eye drops, one drop every hour while awake; and tobramycin and dexamethasone ophthalmic solution with an unspecified treatment modality. Additional treatment with a cryopreserved amniotic membrane insertion was made on (b)(6) 2018. Consumer was advised to stop wearing contact lenses until (b)(6) 2018. Consumer was scheduled for a follow-up appointment and removal of the membrane on (b)(6) 2018. Additional information was received on (b)(6) 2018 via email stating that the corneal ulcer on the left eye has completely healed and that the tobramycin and dexamethasone ophthalmic solution will be discontinued by (b)(6) 2018. The consumer was advised to refrain from contact lens wear until (b)(6) 2018. Additional information has been requested but not yet received.
 
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Brand NameDAILIES TOTAL 1
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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7446137
MDR Text Key106010866
Report Number9610813-2018-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113168
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Catalogue NumberCBV92004051
Device Lot NumberN1151789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
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