MAUDE Adverse Event Report: CIBA VISION BATAM NIGHT & DAY; LENSES, SOFT CONTACTS, EXTENDED WEAR

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

It was reported in a local newspaper article that a patient experienced dry eyes, multiple eye infections, corneal scars and ulcers underneath the contacts.It was reported that the patient indicated that they slept in the lenses for 1-2 months at a time without cleaning the lenses.The patient stated that they were informed that they almost needed a corneal transplant at one time".The patient received lasik surgery and no longer requires contact lenses.The event has resolved.Additional information was requested and is not available.

Manufacturer Narrative

Article citation: wonnenberg, c (12/02/2014)."protect eyes with proper contact care".Retrieved from www.Keloland.Com.(b)(4).Other - manufacturing trend review performed.There was no lot number and the complaint sample is not available for evaluation.No product evaluation was performed.A trend review was performed and no adverse trends were identified.The root cause could not be determined.Internal control number: (b)(4).

• Brand Name: NIGHT & DAY
• Type of Device: LENSES, SOFT CONTACTS, EXTENDED WEAR
• Manufacturer (Section D): CIBA VISION BATAM; batam island ; ID
• Manufacturer (Section G): PT. CIBA VISION BATAM; jl beringin lot #204; batamindo industrial park; batam island ; ID
• Manufacturer Contact: bryan blake ; 11460 johns creek parkway; johns creek, GA 30097 ; 6784153131
• MDR Report Key: 4379990
• MDR Text Key: 5260644
• Report Number: 9681121-2014-00059
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other