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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
Lot Number 31230727
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Corneal Ulcer (1796); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Irritation (1941); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146)
Event Date 07/18/2017
Event Type  Injury  
Manufacturer Narrative
Remedial action changed to n/a from other in the previously submitted regulatory report/s. (b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Remedial action changed to n/a from other in the previously submitted regulatory report/s. The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
This is the second of two reports for the same patient involving two lot numbers of the same product. Please see additional report submitted under manufacturer internal (b)(4). For a description of the first reported lot number. Two opened/used complaint samples were received for evaluation. The samples were received unlabeled; however, based on tool code identification, the samples received were confirmed as consistent with both of the reported lot numbers. The two opened samples were found to meet manufacturing specifications. A retained sample from the same complaint lot (31230727) was tested and was found to meet manufacturing specifications. The device history record and sterilization record for this complaint 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 via telephone, (b)(6) 2017, a patient experienced red eye in the right eye (od) associated with contact lens wear. She sought for medical treatment and she was told that it was likely allergies. She was prescribed with unspecified allergy drops with unknown duration. The patient resumed contact lens wear after resolution of her symptoms and experienced burning, red eyes, and irritation. She continued contact lens wear until her eye appointment a week after. On (b)(6) 2017, she was diagnosed with a corneal ulcer and staph infection. An unspecified steroid and antibiotic drops with unknown duration were prescribed. Warm compress was performed. On (b)(6) 2017, per follow up visit patient was advised to continue the prescribed drops. (b)(6) 2017, per follow up visit ecp told her that her symptoms was resolved and she could resume contact lens wear with a new pair of lenses. On (b)(6) 2017, the patient wore another pair of contact lenses from the complaint lot and felt as if the surface of the contact lenses was very dry. She did not wear too much and took them out regularly. Patient stated that around the 27th or 28th she noticed that she had developed a lump underneath her eyelid. (b)(6) 2017, per final follow up visit, ecp advised her to discontinue contact lens wear, start drops again and perform warm compress. Patient tried the final pair of contact lenses from the complaint lot on (b)(6) 2017 and her eyes became bloodshot red. After the contact lenses were removed, redness and burning were resolved. Additional information has been requested but not yet received.
 
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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
MDR Report Key6959797
MDR Text Key119242648
Report Number9681121-2017-00071
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K033919
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Lot Number31230727
Other Device ID Number000000000010035981-155670800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/18/2017 Patient Sequence Number: 1
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