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

Lot Number 1457590922

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Corneal Edema (1791); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Iritis (1940); Blurred Vision (2137)

Event Date 09/14/2013

Event Type  Injury  

Event Description

A pt contacted us on (b)(6) 2013, stating that she fell asleep in her lenses on (b)(6) 2013, the following day her left eye (os) was irritated.She saw an eye care professional (ecp) that afternoon and was diagnosed with a "hole" in her cornea.Spoke with the ecp on (b)(6) 2013, who stated that the pt was diagnosed with corneal abrasion os, minor hole in the epithelium (basement membrane) os, minor hole in the epithelium which was close to the visual axis but no change in visual acuity (va).Ecp stated that the pt was prescribed vigamox 1gtt qid and systane balance qid.Pt was followed up on (b)(6) and was having some minor allergic conjunctivitis due to vigamox, rx was changed to ciloxin 1gtt qid and the pt was prescribed prednisone 1 gtt qid due to descemet's fold and haze.Pt was seen again on (b)(6) corneal scarring and minor edema noted.Va was 20/25 and ecp stated he imagines va will be 20/20 when treatment is completed.Ecp stated that there is still some add'l nerve fiber damage.Ecp stated that the treatment was not considered aggressive.Spoke with the ecp office staff on (b)(6) 2013 who stated that the ulcer had fully resolved and the pt was due to rtc on (b)(6) for further follow up.At that time, pt was not cleared to return to cl wear.On (b)(6) 2013, we received medical records which provided add'l info as follows: va on (b)(6) 2013 was cc os 20/80.On (b)(6) 2013, pt stated that she had foreign body sensation (fbs).Va os cc 20/40-1.Exam noted 3+ cells and flare.Diagnosis was iritis and os ulcer.Pt was advised to continue the predforte 1% qid and ciloxin qid pt rtc on (b)(6) 2013.Os va cc 20/25-2.Diagnosis was corneal scar os, cmb-mgc ou, and rosacea.Pt was advised to d/c ciloxin and continue with predforte.Pt rtc on (b)(6) 2013.Pt stated that she was using the predforte tid os.Os va 20/20-2.Diagnosis corneal scar os, cmb-mgd ou, and rosacea.Pt advised to taper predforte bid for 2 weeks, qd for 2 weeks and rtc in a month.Pt did not return to clinic following this visit.

Manufacturer Narrative

Twenty nine sealed blisters 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 visual attributes were observed.The solution was also tested.The ph and conductivity were in specification.Based on all available info, no causal factors can be determined and no conclusion can be drawn.Pt factors may have contributed to the event, as these lenses are not approved for overnight wear.Add'l info 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; 5999 richard st.; jacksonville FL 32216
• Manufacturer (Section G): THE SPECTACLE LENS GROUP OF J &J VISION CARE; 5999 richard st.; jacksonville FL 32216
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32216 ; 9044433647
• MDR Report Key: 3591317
• MDR Text Key: 4140728
• Report Number: 1033553-2014-00005
• 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: 01/15/2014

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: 09/01/2017
• Device Lot Number: 1457590922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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
• Patient Age: 42 YR