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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISTAKON ACUVUE OASYS BRAND CONTACT LENS; SOFT CONTACT LENS

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VISTAKON ACUVUE OASYS BRAND CONTACT LENS; SOFT CONTACT LENS Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Headache (1880); Hypopyon (1913); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Discharge (2225); Corneal Infiltrates (2231); Excessive Tear Production (2235); Discomfort (2330)
Event Date 07/14/2013
Event Type  No Answer Provided  
Event Description
On (b)(6) 2014 our firm received a call from a johnson and johnson (b)(4) for skin care products.It is reported that a claims adjuster reached out with a patient (pt) complaint and notification of legal representation by the pt.An e-mail was forwarded to the customer relations department with the attachment received from the claims adjuster.The summary of events in the letter received are as follows: the pt purchased acuvue oasys contact lenses for od and os on (b)(6) 2012.The pt states that as a result of the use of the lenses on (b)(6) 2013, while on a return trip from (b)(6), the pt experienced a sharp pain in his/her right eye.The pt states that he/she removed the contact lenses from his/ her eye, allegedly experiencing redness, pain, discharge, and light sensitivity.It is also advised that the pt sought medical care on (b)(6) 2014.The pt was diagnosed with contact lens induced keratitis of the right eye, with hypopyon.To date, the pt still experiences pain, tearing, light sensitivity, discomfort, and has a visible permanent corneal scar in his/her right eye.An urgent e-mail was sent to the johnson and johnson legal department on october 20, 2014 notifying them of them of the receipt of the document.On october 21, 2014 three e-mails were received from the johnson and johnson legal department with the pt's medical records.Date of eye care professional (ecp) visit: (b)(6) 2013; od red x 2 days; cl wear od; large ulcer with purulent reaction; dx: corneal ulcer; the pt was referred to an ophal.Dept.Date of visit: ophal dept.(b)(6) 2013; chief complaint: blurry vision.Light sensitivity, pain, redness, discharge od; hpi: pt states that her cl's felt as though they were pinching os.Pt removed cl c/o redness, pain, discharge, light sensitivity od; pt flew in from (b)(6) today.Past ocular hx/sx: cl wear.Had in cl x 2 weeks, felt pinch, difficult to remove; pain scale: 10; ocular meds: no gtts; acuvue extended wear 2 weeks; va sc od : 20/60 -2, 20/60-1; ph: 20/60+2 - pt forgot glasses; pupil unequal od; light sensitivity; drawing depicts: infiltrate; od: edema; 3+ injection; 4 x 5 mm infiltrate - epithelial defect.A 4+ cell, hypopyon; impression/diagnosis: cl induced keratitis od with hypopyon; is pt who sleeps in cl; culture taken; plan: fortified vancomycin every hour; fortified tobramycin every hour; cosopt bid; cyclogyl tid; doxycycline 50 mg bid.Date of f/u visit: (b)(6) 2013; cc: evaluate cl induced keratitis od with hypopyon; here for f/u of cl induced keratitis; c/o headache, nausea x 2 days.Ocular medications: vancomycin q1 hour; tobramycin q1 hour; cosopt bid; cyclogyl tid systemic meds: doxycycline 50 mg po bid; past ocular hx: wore acuvue oasys; va sc: 20/hm, 20/50; ph 20/ni, 20/30; pain scale od: 10+.Drawing depicts: 5 x 4 mm infiltrate elevated edges with thinning; dense infiltrate centrally; 4 x 4 mm epithelial defect; hypopyon; od: 4 +injection; 4 x 4.5 infiltrate, dense + epithelial edges; 1.5 mm hypopyon; dilated; impression: contact lens induced ulcer od; + hypopyon; pt feels better but minimal clinical improvement; plan: continue current gtt; f/u 1 day.Date of f/u visit: (b)(6) 2013; cc: evaluate cl induced keratitis od with hypopyon; hpi:+ pseudomonas aureus; ocular meds: vancomycin q1 hour; tobramycin q1 hour; cosopt bid; cyclogyl tid; systemic medications: doxycycline 50 mg po bid; pain scale: 10+; va sc 20/hm, 20/60-2; drawing depicts: infiltrate; 4.5 mm infiltrate; od: 3 + injection; ulcer; hypopyon; impression/plan: ulcer od; send cl for culture+ pseudomonas; decrease vancomycin to 8 x/day; tobramycin 8 x/day; cosopt bid;cont.Doxycycline bid; lop cont.Date of f/u visit: (b)(6) 2013; cc: ulcer od; pain; hpi: ulcer od pseudomonas; ocular meds: vancomycin 8 x/day; tobramycin 8 x/day; cosopt bid; cyclogyl tid; systemic meds: doxycycline 50 mg po bid; va sc: od: hm; 20/70; ph: 20/40-1; pain scale: 5-6; drawing depicts: 3.5 x 3.5 epithelial defect od: edema; 3+ injection; 3 + cells in anterior chamber; dilated.Date of f/u visit: (b)(6) 2013; cc: ulcer od; pain; hpi: ulcer od; pain; past ocular hx/sx: ulcer od; pseudomonas; ocular medications: vancomycin q 2 hours; vancomycin q 2 hours; cyclogyl tid; cosopt bid systemic medications: doxycycline 50 mg po bid; va sc: 20/400, 20/80-2; ph 20/250; pain scale: 8-9; drawing depicts: 3 x 2.5 infiltrate, dense; folds; epithelial defect; hypopyon; od: 3+ injection; 3 x 2.5 infiltrate, dense + epithelial defect; 2 + cells/flare; no hypopyon; dilated.Date of f/u visit (b)(6) 2013; cc: ulcer od pain os/od; hpi: ulcer od; pt c/o shooting pain os/od; past ocular: pseudomonas ulcer od; ocular medications: vancomycin q 2 hour; tobramycin q 2 hour; cyclogyl tid; cosopt bid; pain scale: 9-10; va: sc: od: 20/200; 20/60; ph nl; drawing depicts: folds; no hypopyon; 2.5 x 2.5 infiltrate; od: 3+ injection; 2.5 x 2.5.Date of visit: (b)(6) 2013- emergency apt; history: 62f hx cl - acuvue oasys; keratitis od x 12 days; increased pain 10/10; decreased va; tearing; photophobia; now similar sx os; pain 10/10 os; eye medications: vancomycin q 3 hours; tobramycin q 3 hours; dorzolamide qd; cyclopentolate tid; oral medications: doxycycline 50mg po bid; pain scale: 10; va sc: od: cf 2 1; os: 20/30; drawing depicts: od: 2.2 x 2.0 epithelial defect; os: white and quiet; spk; small abrasion; ac: deep and quiet; no rx.Date of f/u visit: (b)(6) 2013; cc; ulcer od; hpi: ulcer od, pt seen in the clinic on saturday for pain, tearing, light sensitivity, discomfort os - pt states it has since resolved; past ocular hx/sx: pseudomonas ulcer od; ocular meds: vancomycin q 2 hour; tobramycin q 2 hour; cyclogyl tid; cosopt bid pain scale: 3; va sc: od: 20/100; 20/40-1; ph: n1; drawing depicts: od: dense infiltrate 2 x 2 epithelial defect; folds; od: 2+ injection; 2 x 2 infiltrate with epithelial defect.Date of f/u visit: (b)(6) 2013; cc: ulcer od; seeing blue and violet ou; diplopia ou; hpi: ulcer od; pt seeing things in blue and violet ou; also diplopia x 1day; past ocular hx/sx: pseudomonas ulcer od ocular medications: vancomycin q 2 hour; tobramycin q 2 hour; cyclogyl tid; cosopt bid; pain scale: ova sc: od: 20/200; ph 20/150; drawing depicts: dense infiltrate; 1.6 x 1.6 epithelial defect, dense, infiltrate; pigment; od: 2+ injection; 1.6 x 1.6 infiltrate + epithelial defect + edema; impression: improving pseudomonas ulcer od; plan: d/c vancomycin; continue tobramycin q 3 hours; add vigamox q 3 hours; tobrex ointment q hs; continue cyclogyl tid.Date of f/u visit: (b)(6) 2013; cc: evaluate ulcer od; pt feeling better; past ocular hx/sx: pseudomonas ulcer od; ocular meds: vancomycin q 3 hours; tobramycin q 3 hours; cyclogyl tid; tobrex ointment q hs; va sc od: 2080, 20/60; ph: 20/40, 20/30; drawing depicts: folds, edema;1.5 x 2 epithelial defect; od: 2+ injection; 1.5 x 2 epithelial defect, infiltrate; dilated.Date of f/u visit: august 09, 2013; cc: corneal ulcer od, pt was feeling better yesterday - not today, still pain; past ocular hx/sx: pseudomonas ulcer od; ocular meds: tobramycin q 3 hours; vigamox q 3 hours;cyclogyl tid; tobrex ointment q hs; pain scale: 4; va sc od: 20/80, 20/30-1; ph nl; drawing depicts: 1.6 x 1.5 epithelial defect; folds.Epithelial defect; od: 1+ injection; 1/6 x 1.5 epithelial defect.Date of f/u visit: (b)(6) 2013; cc: evaluate corneal ulcer od; hpi: continued tearing ou; especially if works on computer; past ocular hx/sx: pseudomonas ulcer od; ocular meds: tobramycin q 3 hours; vigamox q 3 hours; cyclogyl tid; tobrex ointment q hs; pain scale: 3; va sc: 20/50-2, 20/50; ph 20/40, 20/40+2 - forgot glasses; drawing depicts: infiltrate + scar, folds, no epithelial defect; od: 1-2 + injection; infiltrate, scar, folds.Date of f/u visit: (b)(6) 2013; cc: ulcer od; hpi: ulcer od; past ocular hx/sx: pseudomonas ulcer od; corneal scar od; ocular meds: none; pain scale: 0; va sc: 20/50-1, 20/25-1; ph: 20/25; drawing depicts: scar; no epithelial defect; od: scar.On (b)(6) 2014, an e-mail was received from the johnson and johnson legal department.The e-mail contained a picture of the multipack in question and a copy of the purchase receipt.The lot# of the product was not visible.Sent an e-mail to the johnson and johnson legal department on october 22, 2014 and requested suspect product and lot information, if available.On october 22, 2014 a return e-mail was received from the johnson and johnson legal department advising that the "lawyer did not have the package." the attorney also advised that she would "reach out to the attorney for more product detail, if it is available." no further information is available at this time.
 
Manufacturer Narrative
If add'l info is received, will report within 30 days of receipt.
 
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Brand Name
ACUVUE OASYS BRAND CONTACT LENS
Type of Device
SOFT CONTACT LENS
Manufacturer (Section D)
VISTAKON
jacksonville FL
Manufacturer Contact
rose harrell
po box 10157
jacksonville, FL 32247
9044433647
MDR Report Key4252953
MDR Text Key5015061
Report Number1033553-2014-00099
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/12/2014
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/20/2014
Initial Date FDA Received11/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age62 YR
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