MAUDE Adverse Event Report: CIBA VISION CORPORATION DAILIES AQUACOMFORT PLUS MULTIFOCAL; LENS, CONTACT, (DISPOSABLE)

Lot Number A0385185

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Erythema (1840); Foreign Body Sensation in Eye (1869); Fluid Discharge (2686)

Event Date 01/19/2015

Event Type  Injury  

Event Description

As reported by an eye care professional¿s office, a (b)(6) year old female patient notified them that a contact lens was stuck on the eye, which resulted in two trips to the hospital (no inpatient hospitalization) and caused an ulcer (size and location unspecified).Additional information was received from the treating eye care provider's office via a completed adverse event questionnaire.The patient was diagnosed with a corneal ulcer in the right eye on (b)(6) 2015.The contact lens was confirmed to have been used as a daily disposable and had been used for approximately 8 hours at the time of the event.The duration between symptoms and notification to the eye care provider for treatment was two days.The patient presented with severe foreign body sensation, moderate redness, and watery discharge.There was no anterior chamber involvement and no infiltrates were present.The corneal ulcer was centrally located and 0.5mm in size.There was mild corneal staining present (<50% of the corneal surface), in the area of the corneal ulcer only.The treatment prescribed was an unspecified dosage of an ocular antibiotic.The event is reported to have resolved, without permanent scarring, and contact lens wear has resumed without further issues reported.

Manufacturer Narrative

The complaint product was received and the evaluation is in progress.An investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Manufacturer Narrative

The device history record and sterilization record for this lot have been reviewed and found to be in compliance.Unopened product from the same lot was returned and found to be within specification.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.

• Brand Name: DAILIES AQUACOMFORT PLUS MULTIFOCAL
• Type of Device: LENS, CONTACT, (DISPOSABLE)
• Manufacturer (Section D): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• Manufacturer (Section G): CIBA VISION CORPORATION; 11460 johns creek parkway; duluth GA 30097
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4577310
• MDR Text Key: 5555172
• Report Number: 1065835-2015-00501
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

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
• Device Expiration Date: 02/28/2019
• Device Lot Number: A0385185
• Other Device ID Number: 000000000010097050-155671305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 64