MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC. ACUVUE OASYS BRAND CONTACT LENS; SOFT CONTACT LENS

Lot Number L002318

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Headache (1880); Hypopyon (1913); Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038); Swelling (2091); Blurred Vision (2137); Burning Sensation (2146); Corneal Infiltrates (2231)

Event Date 05/09/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, the patient called our firm to report "bacteria in her contact lens" and that he/she "will need a transplant." the pt advised that on (b)(6) 2014, he/she inserted a new oasys contact lens (cl) od and the lens felt uncomfortable immediately.The pt advised that he/she continued to wear the suspect od cl for about an hour, but then removed it at work.The pt advised that he/she continued to wear the suspect od cl for about an hour, but then removed it at work.The pt advised that on the following day the pt had redness and pain in the od.The pt advised that he/she went to the emergency room and was referred to a cornea specialist.The pt advised that he/she currently has no vision in the od and is waiting six months "to see if his/her eye will heal well enough to support a corneal transplant.Pt states he/she has a scar in center of his/her eye and no vision from that eye.He/she did not know what drops he/she was using, but is currently not using drops other than theratears prn." on (b)(6) 2014 the pt sent an e-mail stating that "i currently have a vision of fingers in my right eye.When i have to complete the cornea transplant surgery i would like that to be covered to try to get my vision back.I do not have the original contact because i need to get rid of anything else that would add contamination to effect my child.I have the original box with at least 2 contact lens.When i get home or during this weekend i will email you my eye medical documents for your review, to this email and prepare the shipment of the contact lens that i have." on (b)(6) 2014 the patient forwarded partial medical records via e-mail for treatment of the event.Date of visit: (b)(6) 2014 - er visit; no information included on record for er visit.Date of visit: (b)(6) 2014 - office visit; diagnosis: corneal ulcer with hypopyon, right.; reason for visit: eye pain; hpi: severity of the pain is severe.This started 4 days ago.In the right eye.Symptom occur: constant; characterized as sharp; associated symptoms include red eye, blurred vision and red and/or swollen lids.Since onset it is better but still present.Treatments include topical antibiotics.Comments: contact lens wearer; base eye exam: od: dist cc: method: snellen - linear: hm; slit lamp and fundus exam: od: external: normal; lids/lashes: mild edema; conjunctiva/sclera: 3+ injection; cornea: infiltrate superonasal 4.8 (v) x 5.2 (h); anterior chamber: layered hypopyon - 1mm; iris: round and reactive; lens: clear; vitreous: normal.Status: cl related corneal ulcer od, pseudomonal; 3+ pseudomonas growing on cultures; stop vancomycin; add vigamox q2 hours od; tobramycin q2 hours; rtt 2 days, return precautions discussed.Date of visit: er (b)(6) 2014; complaint: painful od; cl user; pain in right eye since (b)(6) 2014; diagnosis: corneal ulcer (including herpetic), right; medications: cyclogyl 1% place 1 drop in od tid; tobradex 1 drop to od q 2 hours; vigamox 0.5% place 1 drop in od q2 hours while awake; atropine 1% place 1 drop in od bid; pain level: 8; ed notes: ulcer improving with less purulence and resolved hypopyon;continue current drops.Comments: swelling, redness, photosensitivity, burning since mother's day.(on vigamox and tobramycin (not fortified) - q1 hour during the day and q 2 hours at night + atropine bid + doxy and vit c).Seen by cornea specialist who was concerned as increased thinning superotemporally; responding very slowly; h/o pseudomonas ulcer, sensitive to tobra and levoflox.Base eye exam: od: dist cc: lp, hm; pressure 16; method: tonopen; pupils dark, perrl; slit lamp and fundus exam: od: normal; lids/lashes: normal; conjunctiva/sclera: 1-2+ injection; cornea: inflammation (plaque), 20-40% thin, most thin st; anterior chamber: 3+ cell, no hypopyon; iris: round and reactive; lens: clear; vitreous: normal; periphery: normal (superiorly) rest of exam limited by ulcer.Ed course, summary and plan: corneal ulcer od, known pseudomonas + significant thinning.Responding to treatment - continue current drops (vigamox and tobra (not fortified) q1-2 and atropine; add preforte qid od; (discussed r/b/a and strict rsvp since starting steroid).Discussed with cornea specialist.Preservative-free artificial tears prn comfort; corneal cultures deferred since responding (ulcer smaller compared to 5 days ago); return to triage in 2 days; perforation and rsvp precautions given.Medications: prednisolone acetate 1% ophthalmic suspension, 1 drop in od qid; atropine 1% place 1 drop in od bl d; cyclogyl; vibramycin 50 mg capsule; vigamox 1 drop od q 2 hours while awake for 30 days; tobrex.Date of visit: (b)(6) 2014 - office visit; diagnosis: corneal ulcer of the right eye; reason for visit: corneal ulcer; hpi: od.Sees better; less pain; still photophobic; has h/a when tries to focus too long; saw corneal specialist 1 week ago; vision is much better; pain is 3/10; base eye exam: od: visual acuity: dist cc: 20/80 +1; dist ph sc: nl; method: snellen- linear; tonometry od: pressure 16; method: tonopen; slit lamp and fundus exam: od: external: normal; lids/lashes: normal; conjunctiva/sclera: 1-2 + injection; cornea: 3.6mm stromal infiltrate with mcke, no ked, 30% thinning inferiorly; anterior chamber: trace cell; iris: round and reactive; lens: clear; vitreous: normal; status: contact lens related pseudomonas corneal ulcer od; improving, va significantly improved; on pf without recurrent ked but with some stable stromal thinning (approx 30%); continue vigamox/tobramycin qid and then just add tobra after running out of vigamox; pf qid, doxycycline bid; vitamin c 1000 mg po qd; rtc cornea specialist on friday.Date of visit: 05/30/2014 - office visit; diagnosis: corneal ulcer of the right eye; hpi: pt feeling slightly better; medications: tobramycin qid od; pf qid od; doxycycline 50 mg po bid; vitamin c 100 mg po bid; base eye exam: od: dist cc: 20/80; dist ph cc: 20/50-; method- snellen; pressure 23;slit lamp and fundus exam od: external: normal; lids/lashes: normal; conjunctiva/sclera: 1-2+ injection; cornea: 3.6mm stromal infiltrate with mcke, ked present, 30% thinning inferiorly; anterior chamber: trace cell; iris: round and reactive; lens: clear; vitreous: normal; peripheral: normal (superiorly), rest of exam limited by ulcer.Status: contact lens related pseudomonas corneal ulcer od; improving, va significantly improved; on pf with reappearance of ked but with some stable stromal thinning (approx 30%); continue tobra gtt qid; pf qid,can d/c doxycycline bid; d/c vitamin c; rtc corneal specialist at next visit.

Manufacturer Narrative

Multiple unsuccessful attempts have been made to obtain the pt's complete medical record through the pt and the pt's treating eye care professional (ecp).Also multiple unsuccessful attempts have been made to obtain the suspect product for evaluation, but it has not yet been received.A lot history review was performed and revealed the batch did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.

• Brand Name: ACUVUE OASYS BRAND CONTACT LENS
• Type of Device: SOFT CONTACT LENS
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC.; limerick ; EI
• Manufacturer Contact: rose harrell ; po box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 4316389
• MDR Text Key: 20978150
• Report Number: 1033553-2014-00110
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2014

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: Other
• Device Expiration Date: 03/01/2018
• Device Lot Number: L002318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/04/2014
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SINGULAIR; VENTOLIN INHALER; ABILIFY; CELEXA; CLEARCARE SOLUTION; FLONASE; NEXIUM; ZYRTEC
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 73