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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 31218132
Device Problem Insufficient Information (3190)
Patient Problems Corneal Ulcer (1796); Irritation (1941); Itching Sensation (1943); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Increased Sensitivity (2065)
Event Date 08/12/2017
Event Type  Injury  
Manufacturer Narrative
The complaint product was returned for evaluation and was found to meet manufacturing specifications. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. The manufacturing review did not indicate that this complaint was due to the manufacturing process. No complaint or manufacturing trend was identified. The root cause could not be determined.
 
Manufacturer Narrative
The actual complaint product was not returned for evaluation. A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications. A trend related investigation was performed; no trend could be identified. 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
It was reported by a female patient that she experienced itchy eyes, redness, irritation and ulcers on her left eye (os) from wearing the complaint contact lenses. It was added that the symptoms were resolving and the eye drops were reduced to four times a day. The patient mentioned that "the ulcer was so bad that a mesh was put on her eye and a band aid on top of that". Additional information was received on 10/24/2017 via faxed medical records. It was reported that the patient visited an optometrist on (b)(6) 2017 due to a red os. While wearing contact lenses a day prior, her os started to bother her so she removed the contact lenses. She used a new pair of contact lenses and her os started to be really itchy. She removed the contact lenses but the itchiness got worse. The os was throbbing with sharp shooting pains, was watery and was sensitive to light. Slit-lamp observations include a large central corneal ulcer os with haze surrounding it, 2+ bulbar conjunctiva injection os. The patient was diagnosed with central corneal ulcer, os. She was prescribed with ketorolac 0. 5%, one drop into the affected eye four times a day as needed for pain, tobramycin/dexamethasone 0. 3-0. 1% and 1 drop into affected eye four times a day for seven days. While in the doctor¿s office, she was also given one drop of homatropine (os), 1 drop of proparacaine (os), a 12 millimetre (mm) amniotic membrane was inserted on the ocular surface (os) and a bandage contact lens was placed over it. She was prescribed with moxifloxacin (os) every hour for one day and every two hours for the next two days. She was also scheduled for a follow up visit three days after. On (b)(6) 2017, the patient visited the optometrist for a progress check on the corneal ulcer (os). The patient reported that she felt a lot better and that she thought that a part of the amniotic membrane came off but the contact lens was still in place. She added that pain and light sensitivity was much better and the pain medications helped a lot. Slit-lamp observations include a much better central corneal ulcer with haze surrounding it and 1+ bulbar conjunctiva injection (os). The bandage contact lens was removed and the patient was instructed to continue with moxifloxacin six times a day for two days, then four times a day (os). She was diagnosed with central corneal ulcer, os and was also scheduled for a follow up visit three days after. On (b)(6) 2017, the patient visited the optometrist for a progress check on the corneal ulcer (os). The patient reported that the os was feeling much better. Slit-lamp observations include a small central corneal ulcer os ¿ no sodium fluorescein (nafl) staining present. She was prescribed with ketorolac 0. 5%, 1 drop into affected eye four times a day as needed for pain, tobramycin/dexamethasone 0. 3-0. 1%, 1 drop into affected eye four times a day for seven days, moxifloxacin 0. 5%, 1 drop into the left eye. For the treatment of the cornea, she was prescribed with tobramycin/dexamethasone four times a day for one week (os). She was diagnosed with central corneal ulcer, os. Additional information was received on 10/27/2017 via a telephone call. It was reported that all of the symptoms have resolved. Additional information was received on 11/09/2017 via faxed medical records. On (b)(6) 2017, the patient reportedly put on a new pair of non-alcon contact lenses and slept in them. On (b)(6) 2017, the patient experienced red eye which was throbbing and tearing. On (b)(6) 2017, the patient¿s eye had secretions and felt scratchy upon waking up. It was reported that the patient visited an optometrist on (b)(6) 2017 due to red os. Slit-lamp observations include corneal infiltrates superior temporal limbus os, 2+ bulbar conjunctiva injection os. The diagnostic impression was infiltrative keratitis superior temporal, os. The patient was prescribed with tobramycin/dexamethasone 0. 3-0. 1%, one drop into affected eye four times a day for seven days. She was advised to throw away the current contact lenses and discontinue contact lens wear and was scheduled for a follow up visit after four days. She was diagnosed with marginal corneal ulcer, os. On (b)(6) 2017, the patient visited the optometrist for a recheck on the red os. The patient reported that the eye was feeling much better. Slit ¿lamp observations include an almost resolved corneal infiltrates superior temporal limbus os and tr-1+ bulbar conjunctiva injection os. The diagnostic impression was almost resolved infiltrative keratitis superior temporal, os. The patient was advised to continue tobramycin/dexamethasone 0. 3-0. 1%, one drop into affected eye four times a day for three days and start with new contact lenses. She was diagnosed with marginal corneal ulcer, os. Additional information was received on 11/10/2017 via a telephone call. It was verified by the physician and the patient that the patient had never worn any other contact lens beside the alcon contact lenses and that there was a mistake on the medical records received on 11/09/2017.
 
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Brand NameAIR OPTIX NIGHT & DAY AQUA
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
PT. CIBA VISION BATAM
beringin kav. #204 batamindo
industrial park muka kuning
pulau batam 29433
ID 29433
Manufacturer (Section G)
PT. CIBA VISION BATAM
beringin kav. #204 batamindo
industrial park muka kuning
pulau batam 29433
ID 29433
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7032078
MDR Text Key119242311
Report Number9681121-2017-00072
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073459
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 12/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Lot Number31218132
Other Device ID Number000000000010043925-155700001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/15/2017 Patient Sequence Number: 1
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