• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number CBV92002040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Unspecified Infection (1930); Pain (1994); Pain (1994); Ulcer (2274)
Event Date 12/01/2019
Event Type  Injury  
Manufacturer Narrative
This is the first of two reports for the same patient involving two lot numbers of the same product. It is unknown which contributed to the event. Refer to (b)(4) for the reported lot number 31369413. There is no return sample received from complainant during the report is being made, therefore no product evaluation can be performed. As no product has been returned, the investigation was solely based on a review of the manufacturing records for lot 31369413. The manufacturing investigation through device history record review of lot 31369413 has been conducted. This lot has gone through all manufacturing process stages as required by the procedures. There was no nonconformity related to the nature of complaint occurred during the manufacturing process. All in-process inspection records and final product inspection record confirmed to be within specifications. The dry lens fa # (b)(4) was assigned to lot 31369413 and confirmed met the molding process specifications. This lot has gone through 100% wet visual cosmetic inspection following standard operating procedures. The aql sampling taken for visual cosmetic quality at qc online primary packaging inspection, qc mantis sampling inspection and final cosmetic sampling inspection at qc pai were confirmed to meet the acceptance criteria. The lot 31369413 was processed at primary packaging machine # (b)(4). The sampling taken for package integrity during primary packaging process, qc mantis sampling inspection, and qc post autoclave inspection were within the specifications. The batch record of saline packaging solution # (b)(4) that used for this lot has been reviewed and met the specification. The sterilization process parameter and bi incubation result also met specifications. Infectious corneal ulcer is often referred to as ¿microbial keratitis¿ or ¿infectious keratitis¿. This case causes by a microbial agent i. E. Bacterial, viral, fungal, or amoeba. The manufacturing site has inspected the product retain samples of lot 31369413 to ensure whether there is any possibility of product contamination, therefore package integrity inspection of retain samples was performed by visually inspection and vacuum testing to ensure there are no leaks or other package integrity defects that could lead to contaminate product. 12 retain samples inspected showed to meet specifications, no package integrity defect found. The complaint data and trend related to ¿h-infection - not otherwise specified (moderate); h-eye pain; h-corneal ulcer infectious¿ for lotrafilcon a product has been reviewed and did not indicate any adverse trend, overall data metrics are within the control limit. Tracking in complaint database, there was no other similar complaint reported to this lot. Based on the investigation, this lot has passed through all manufacturing process as required by the procedures. The lot was confirmed to meet all in-process and finished product specifications at the time of release. This complaint can be considered as an isolated case as there is no other similar complaint reported to this lot. No root cause can be determined. There is no impact to the other product and no field action assessment (faa) is required. No corrective action preventive action (capa) will be initiated for this complaint. Continuous monitoring of these types of events through trending and analysis may indicate future action. (b)(4).
 
Event Description
It was reported by an eye care professional (ecp) that a patient was seen on (b)(6) 2019 for a routine eye examination and the patient was asymptomatic at the time of visit. The patient was seen by an ophthalmologist following the routine eye examination and was diagnosed with an eye infection. The date of medical intervention as well as eye involved was unknown. The patient was then referred to a healthcare facility. Additional information was received on (b)(6) 2019 via a telephone call from the office of the ecp. It was reported that the patient visited on (b)(6) 2019 after contact lens fitting on (b)(6) 2019. It was noted that the patient was a competitive swimmer. The patient woke up in pain and changed out the original contact lens. The patient placed the second lens in his eye and continued to have pain which quickly progressed. The patient was then referred to a healthcare facility. On (b)(6) 2019, it was mentioned that the patient was getting better. On (b)(6) 2019, the patient was diagnosed with ulcer of the right eye (od) and was prescribed with moxifloxacin, treatment modality unknown. The patient was scheduled for a follow up visit on (b)(6) 2019. Additional information has been requested but not yet received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jason michaelides
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686438
MDR Report Key9537118
MDR Text Key189201429
Report Number9681121-2019-00020
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
2 Patients were Involved in the Event: 1   2  
Date FDA Received01/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCBV92002040
Device Lot Number31369413
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2018
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: 01/01/2020 Patient Sequence Number: 0
-
-