|
On 04may2018 information was received from a patient (pt) via a social media site.The pt reported a recent contact lens brand switch to an acuvue brand contact lens (acuvue brand was not provided).Pt reported experiencing burning after about an hour of wear and readjusted the lenses, but the symptoms continued.The pt continued to wear the lenses for about 5-6 hours and then went to an emergency room (er).Pt reported ¿i am near blind and cannot see anything but a blurred horizon without corrective lenses¿.Pt reported the lenses ¿burnt a hole through my cornea¿.Pt has 4 follow-up visits with a cornea specialist and is continuing treatment.Pt reported ¿the worst pain i have ever experienced¿.On 10may2018 a call was received by the pt who provided additional information: pt reported the symptoms began on (b)(6) 2018 and went to the er on (b)(6) 2018.Pt was originally prescribed the lenses in (b)(6) 2018.Pt reported itching while wearing the lenses and would have to change them lenses 2-3 times daily.Pt reported one morning after working the night shift and wearing glasses, pt inserted the 1-day acuvue moist lenses and they began burning.Pt continued to wear the suspect lenses for 4-5 hours, then removed and discarded the suspect lenses later at home.After the suspect lenses were removed the os continued to burn so, pt repeatedly flushed the os with saline.The pt went to the er on (b)(6) 2018 and reports a diagnosis of allergic reaction and corneal ulcer os.The pt was referred to a corneal specialist the same day.On 14may2018 a call was placed to the pts treating eye care provider (ecp) and spoke with a representative who provided additional medical information: the pt was diagnosed with a marginal corneal ulcer os and is currently in treatment and is slowly improving.On 04may2018 the pts medical records were received from the er visit: date of visit: (b)(6) 2018: chief complaint: pt c/o bilateral eye irritation/redness after starting new contacts 2 days ago; pt presents with a chief complaint of os redness and irritation.Pt states that she has been using a different brand of contact lenses than normal.Pt denies any acute vision changes, headache, dizziness.Pt states they are clear tears, but no drainage.Pt has no other symptoms.Medications: polymyxin b-trimethoprin (polytrim) 10,000 unit/1 mg/ml drop; place 1 drop tid daily for 7 days, starting (b)(6) 2018 until (b)(6) 2018.Physical exam: eyes: within/without fluorescent dye evaluation there is a small, round, 2 mm corneal ulceration at approximately 2 o¿clock at the limbic border of the left eye, otherwise bilaterally there is some inflammation with no other abnormalities with upper and lower eye lid eversion.Medications administered in the er: proparacaine (alcaine) 0.5 % ophthalmic solution ads.Final diagnosis: marginal corneal ulcer of the os; acute atopic conjunctivitis pt referred to an ophthalmologist.Pts medical records received from pts treating ecp received on 23may2018: date of visit: (b)(6) 2018: chief complaint: k-ulcer os; discomfort started (b)(6) 2018; woke today with pain; os ¿ blurred with symptoms, pain 9 of 10; photophobia; pt recently switched to a new brand ¿ cl wear for 1.5 years; at ¿ prn; + nsaids.Exam: pupil: os: pupil: 4/3; conj: 2+ inj; granularly peripheral/sub epithelial infiltrate, temporal with cellularly + wbc opaque reaction; a/c: 1+ cell; i: flat; lens: clear.Diagnosis: k ulcer os, not threatening va; no cl use until this resolved; start vigamox q 1 hour while awake today, then q 2 hours till monday; use tylenol; use sunglasses for photophobia; start pred ac os monday after appointment; return monday.Date of visit: (b)(6) 2018: chief complaint: k ulcer os x 3 days check; va ¿ no change; not wearing cl in os; + pain os; burning, better than friday; vigamox q 2h; at prn.Exam os: conj; minimal; cornea: corneal infiltrate, 1.5 mm surrounding micn cystic edema; epi-defect; a/c: tr cell; iris: flat: lens: clear.Diagnosis: k infiltrate os; cont vigamox qid os; start tobradex qid os; moxiflox refill; rtc friday.Date of visit: (b)(6) 2018: chief complaint: fu k infiltrates os x 3 day; va was blurred the past few days (os) but seems better today; no pain; no photophobia; vigamox qid; vigamox qid os; pt states she has vomitus after tobradex, thrown up 3 x, used tobradex 8-10 x; pt states the pain was likely making her sick.Exam os: va: 20/30; cc glasses: 20-3; conj: clear; cornea: infiltrate 1.4 mm pinpoint epi stain; microcystic edema; + cells; a/c: trace; iris: clear; lens: clear.Diagnosis: k-ulcer os; cpm with vigamox and tobradex qid; rtc tuesday.Date of visit: (b)(6) 2018: chief complaint: fu k-ulcer os x 5 days; va seems better; no pain; no photophobia; pt hasn¿t thrown up again since last visit; taking vigamox and tobradex qid os.Visual field: os: 5-4.Exam os: conj: clear; cornea: 1.3 mm infiltrate; tr staining; tr epi defect; microcystic stromal edema; a/c: clear; iris: clear; lens: clear.Diagnosis: k ulcer os improving; cpm with vigamox and tobradex os qid; no ctl wear; discussed lasik as possibility in future after resolved; rtc wed/thurs next week.Date of visit: (b)(6) 2018: chief complaint: occasionally feels like something in the os x 5 days; fu k-ulcer os x 5 days; va some more blurry os; no pain; no photophobia; no ctl wear; + vigamox and tobradex qid os.Va os: 20/20-1; 50 + 1, cc/glasses: 20/25-2.Exam os: conj: clear; cornea: < 1 mm infiltrate; central staining; less opaque; microcystic stromal edema; a/c: clear; iris: clear; lens: clear.Diagnosis: k-ulcer os (less opaque) improving; no ctl wear; cpm with vigamox and tobradex qid os; rtc 1 week.Date of visit: (b)(6) 2018: chief complaint: os 1 week check; no pain; no fbs; va os worse gradually; + vigamox and tobredex qid os.Va os: 20-2; 20/40-1 cc with glasses.Exam os: conj: clear; cornea: pin point stain; less opaque; stromal microcystic edema; a/c: clear; iris: clear; lens: clear.Diagnosis: k ulcer improving; vigamox qid os; pred qid os; d/c tobradex; rtc: 1 week.On 04jun2018 a call was placed to the pts treating ecp and a representative provided additional information: the pt returned on (b)(6) 2018 with ¿pin point¿ opaque stain os; corneal ulcer resolved; va os not affected; pt to continue the prednisone for 1 week bid os and then discontinue use; pt has not returned to cl wear and is to rtc in 1-2 months to discuss lasik; pt is currently wearing glasses.No additional information was received and no additional information is expected.The suspect product was discarded.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot 2084550104 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
|
