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Device Problem Disposable
Event Date 04/05/2007
Event Type  Injury  
Manufacturer Narrative

Device labeling single use or reuse.

Event Description

A pt reported being changed to acuvue oasys contact lenses in 2007. Three months later, the pt visited an optometrist complaining of red, itching od for one week. The pt also complained of burning, and light sensitivity in the od. The pt had self-treated with refresh gel drops and opcon a eye drops without relief. The pt was reported to have dense spk od with 2+ conjunctival injection and mild follicles. The pt's anterior chamber was clear. The pt was treated with quinxin gtts qid and refresh plus drops q1h and return to clinic in 24 hours. The next record dated for 2007 notes, the pt had another visit since the initial visit. At that visit, quinxin was discontinued and pt was instructed to use artificial tears only. Eight days latrer, visit the pt had photophobia and pain ou and could not open both eyes. The pt was found to have corneal filaments ou, grade 4 spk ou, superior corneal infiltrates ou and trace cells in the anterior chambers ou. Diagnosis: filamentary keratitis with extreme spk ou. Rx vigamox q1h ou; refresh pm at hs; systane q1h; nevanac gtts. The pt returned two days later. Photosensitivity was improving and pt reported eyes felt better. The optometrist notes the pt had no filaments, vision blurry, eyes painful. Pt had 2+ conjunctival injection. Pt had superior infiltrates os that were positive for fluorescein stain. Pt's va od 20/150; os 20/200. Assessment: extreme dry eye with staph ulcers os. Treatment od: bandage soft contact lens, acuvue oasys +0. 50 d with refresh plus q1h. Os: tobradex qid plus refresh plus q1h. Note: "if ulcers healed tomorrow, cl os". From 17 april 2007 through 14 may 2007, the pt was treated by a different optometrist. The optometrist reported the pt's va on 17 april was od 20/80 and os 20/100. Diagnosis: marginal corneal ulcer, medicamentosa ou. Treatment: vigamox bid ou, 1% pred forte 1 drop ou q1h. Artificial tears q2h, discontinue bandage contact lens. The ecp notes pt has 2+ circumlimbal conjunctival injection ou with diffuse spk od. Os the marginal ulcers have healed over but have dense underlying infiltration. There is a dense diffuse spk from medicamentosa ou. The bandage contact lens "is aggravating limbal areas preventing healing - looks as if there may be a sensitivity to oasys material. " the pt returned three days later: no change in diagnoses, treatment: taper pred forte q2h x 2 days, then q4h x 2 days. Artificial tears q1h, discontinue vigamox. The next month pt's diagnosis: spk. Meds: 1% pred forte ou bid. The same month: va od 20/50, os 20/40. Diagnosis: keratitis, medicamentosa. Treatment: continue artificial tears q2h. The ecp notes the pt has pseudodendritic epithelial keratitis ou. Note: "drastic improvement in central cornea - still has whorlike pattern and epithelial haze in each eye os > od. " four months later. Pt returned for recheck and reported everything is good, the pt is still using artificial tears. Va od 20/40, os 20/30. Treatment: continue artificial tears q2h, lid scrubs, add collagen plug inferior od to improve corneal healing. The ecp's note indicates pt still has whorlike patter and epithelial haze ou. There is more diffuse spk at this visit. The pt had follow up visit with an ophthalmologist fo. The pt's va od 20/25, os 20/20. Impression: spk. Treatment: add claritin po and fml qd am. The pt returned to the ecp fourteen days later for follow-up. Pt was noted to have corneal stippling od. Diagnosis: chronic keratitis. Treatment: discontinue fml. Continue claritin and non-preserved artificial tears 2x day. Return to clinic in 2 weeks. The pt did not return to clinic. Spoke with the treating optometrist who saw the pt between in 2007. He said, he felt the pt developed marginal corneal ulcers which were not serious and the pt was, in his opinion, over treated with antibiotics. He said the preservatives in the antibiotics caused a toxic reaction, medicamentosa, which was the cause of the dense spk ou. The ecp noted that the pt's vas at the last visit were od 20/25-2 and os 20/20. The ecp noted that the pt had a central corneal scar od and 20/25 -2 was bcva. The pt had reported being treated for a central corneal ulcer in the od. The pt did not know what brand of contact lenses were worn at that time. The pt discarded the lenses in question and was unable to provide lot numbers. No additional info is expected. This report is to document the adverse event in the pt's os. The od event is documented in mdr# 1033553-2008-00009. All mdr events are reviewed at quarterly management review meetings.

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Manufacturer (Section D)
jacksonville FL
Manufacturer Contact
terry meisner
p.o. box 10157
jacksonville , FL 32247
MDR Report Key989618
Report Number1033553-2008-00010
Device Sequence Number1
Product CodeLPL
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 01/31/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/10/2008
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 Unkown

Date Received: 01/31/2008 Patient Sequence Number: 1