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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR

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PT. CIBA VISION BATAM AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92000509
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Abrasion (1789); Corneal Ulcer (1796); Irritation (1941); Pain (1994); Red Eye(s) (2038); Swelling (2091)
Event Date 06/22/2018
Event Type  Injury  
Manufacturer Narrative
This is the second of two reports for the same consumer involving two lot numbers of the same product. It is unknown which contributed to the event. Refer to 2018-65521-01 for the reported second lot number 31314054. 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. (b)(4).
 
Event Description
As initially reported by a consumer through email on (b)(6) 2018, the consumer had recurrent bacterial infection which led to ulcerations, specifically affecting her right eye only, with the use of the set of contact lenses that she purchased dated (b)(6) 2018. The consumer detailed that she has tried using 3 different contact lenses from the same set, using them not longer than 2 weeks and still experienced the same signs and symptoms on the right eye. The consumer stated that the infection was extremely painful that it had affected her activities of daily living (adl). She also claimed that the recurring infection had resolved only after using an expensive unknown medication with unknown treatment modality prescribed by her eye care provider (ecp). Received additional information from the consumer through email on (b)(6) 2018 stating that initial redness on her right eye occurred on (b)(6) 2018 after wearing a pair of contact lenses from her 6-month supply. The redness and irritation subsided almost completely after the consumer stopped using the contact lenses. The consumer added that she had not worn contact lenses for almost two weeks after the initial symptoms. When she decided to use contact lenses again, she had utilized a new pair from the same pack. After about a week of wearing the said contact lenses, the consumer felt eye irritation again. The second occurrence was dated (b)(6) 2018 where the consumer opted to seek medical advice immediately due to severe pain alongside with redness and swelling. The consumer¿s eye care professional (ecp) diagnosed her with two corneal ulcers in her right eye. The consumer was then given ciprofloxacin hcl ophthalmic antibiotic solution with an unknown treatment regimen and was advised to rest her eyes and discard the remaining contact lenses and other eye-care products that came in contact with the infected eye to prevent contamination. The consumer elected to use the third pair of contact lenses again after not even a week of wearing them. She then mentioned that the third occurrence happened on (b)(6) 2018 where she again experienced pain, redness and swelling prompting her to seek medical attention immediately. The ecp then diagnosed her to have corneal ulcers again. She was then prescribed with another unknown ophthalmic solution with unknown treatment regimen. The consumer affirmed that she takes care of her contact lenses. She also added that the issue occurred with three different lenses and all from the right contact lenses of the same pack and that the contact lenses were not torn. The symptoms she experienced were resolved when the contact lenses were removed and subsided with the help of prescription ophthalmic solutions. The consumer also stated to have resumed contact lens wear and have not experienced any issue or infection at all. Received additional information from the eye care provider (ecp) through email on (b)(6) 2018. The ecp stated the consumer had recurring corneal ulcer in the right eye, which required the consumer to undergo eye treatment regimens in the past few months. The ecp explained that the eye condition would fully resolve every after the consumer adheres to the treatment regimen but however would come back upon wearing contact lenses. Lastly, the ecp added that the consumer experienced irritation or abrasion to the right eye leading to the recurrent ulcers.
 
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Brand NameAIR OPTIX FOR ASTIGMATISM
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
bryan blake
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key8018237
MDR Text Key125432881
Report Number9681121-2018-00011
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2022
Device Catalogue NumberCBV92000509
Device Lot Number31308608
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/30/2018 Patient Sequence Number: 1
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