MAUDE Adverse Event Report: VISTAKON ACUVUE 1-DAY TRUEYE NARAFILCON B; DISPOSABLE SOFT CONTACT LENS

Lot Number 1456400222

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038)

Event Date 01/09/2014

Event Type  Injury  

Event Description

The patient (pt) emailed us to report he had experienced an ulcer in his left eye (os) after using trueye contact lenses (cl).On (b)(6) 2014, we spoke to the pt who stated, a couple weeks ago, his eye was red and irritated.Pt stated he removed contact that day.Pt stated that he started to experience photophobia the following day so he saw his eye care professional (ecp).Pt stated that he was treated with eye drops.Pt stated that his va has changed and he can see the scar on his eye.Spoke with the ecp on (b)(6) 2014, who stated the pt presented on (b)(6) 2014 with an os peripheral ulcer, less than 1mm, 1:30 position.Va was 20/25, no va prior to the injury was available.Ecp stated the ulcer was not in the visual axis.Ecp considered it a bacterial infection but did not culture it.Pt was treated with besivance, q2h for a week.Ulcer was mostly resolved at the end of the week, advised to continue at tid for a week.Pt has a small scar and the ulcer has resolved.Va was 20/30 on final visit, ecp stated he did not feel the va had changed due to the ulcer.Pt has returned to cl wear.

Manufacturer Narrative

Seventeen lenses were returned.The parameters of ten lenses were measured and a visual inspection was performed.The lenses meet company standards for base curve, center thickness, and diameter.No other visual attributes were observed.The solution was also tested.The ph and conductivity were in specification.A lot history review was performed and revealed the following: the batch record did not show any abnormities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot #1456400222 was produced under normal conditions.Based on all available information, no causal factors can be determined and no conclusion can be drawn.Additional information will be submitted within 30 days of receipt.Mdr reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE 1-DAY TRUEYE NARAFILCON B
• Type of Device: DISPOSABLE SOFT CONTACT LENS
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3650034
• MDR Text Key: 4284736
• Report Number: 1033553-2014-00016
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/10/2014

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
• Device Expiration Date: 06/01/2017
• Device Lot Number: 1456400222
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention