MAUDE Adverse Event Report: CIBA VISION STERILE MFG (CA) AQUIFY; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The complaint sample is not available for evaluation; the lot number is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Patient event code (b)(4) designated for vascularization, epithelial defect.

Event Description

As reported via a literature report entitled, "contact lens-related acanthamoeba keratitis and accompanying dacryoadenitis" (eye & contact lens volume 41, number 4, july 2015), case #4 details the following events: a (b)(6) male patient came to the clinic with complaints of hyperemia, blurriness, and intensive crusts in the left eye.From his history, it was learned that he used silicon hydrogel contact lenses (-4.5 d, base curve: 8.60 mm, diameter: 14.00 mm; balafilcon a, bausch & lomb) on daily wear monthly replacement and was using a multipurpose contact lens solution (containing polyhexanide %0.0001, sodium phosphate, tromethamine, poloxamer, disodium edta; ciba vision).On his history, he told that he did not take his lenses off in the shower or the sea, that he did not consult an ophthalmologist when changing lenses and lens care solutions, and that he bought the lenses of his own preference on the internet.Eye examination revealed visual acuity of 20/20 in the right eye and 20/200 in the left eye, and biomicroscopy demonstrated conjunctival hyperemia in the left eye with excessive purulent secretion and a 6·6 mm ring-shaped epithelial defect accompanied by stromal edema.In addition, swelling, pain, and redness of the left lacrimal gland were detected.There was moderate temporal left upper eyelid ptosis.No abnormal findings concerning the right eye were observed.In the laboratory examination, gram-positive cocci were detected in gram staining of corneal swab samples, but the culture results were negative.On observing acanthamoeba trophozoites and cysts on confocal biomicroscopy, a mixed infection consisting of acanthamoeba and gram-positive bacteria was assumed to be present.The treatment used consisted of topical 0.1% propamidine isethionate¿every hour, moxifloxacin¿6x2, fortified-gentamicin¿6x2, multipurpose contact lens solution (polyquad 0.001%, aldox 0.0005%)¿6x2, and oral itraconazole 100 mg¿1x2.In the following 15 days, a decrease in the purulent secretion and shrinkage in the ulcer were observed.However, 1 month later, the epithelial defect on the ulcer was seen to have become even wider than before.Considering drug toxicity, the dose of the topical drops was reduced.The epithelial opening decreased gradually within 8 months, vascularization progressed from the lower temporal area, and a vascularized leucoma was formed.After a long period of treatment (10 months), the visual acuity of the left eye improved (20/100), corneal epithelial defect closed totally, leaving a vascularized leucoma, and accordingly, swelling and redness of the left lacrimal gland subsided simultaneously at the end of 10 months.Also, the control mri showed that the lacrimal gland was in the normal size and contrast without any radiologically visible sequelae.The stated objective of this report was to discuss the clinical presentation, diagnosis, therapy, and methods for prevention of acanthamoeba keratitis (ak) and to emphasize that inflammatory dacryoadenitis can be seen together with it.The article concluded that, despite the improvements in diagnostic tests and treatment strategies for ak, the role of prevention becomes apparent because of the bad prognosis of this serious complication; thus, contact lens wearers should be aware of the importance of using lenses under ophthalmologist¿s supervision.In addition, it was emphasized that ak may be frequently associated with lacrimal gland inflammation.

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.(b)(4).

Event Description

Final report: no additional information has been received.

• Brand Name: AQUIFY
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer (Section G): CIBA VISION STERILE MFG (CA); 6515 kitimat road; mississauga, ontario L5N 2 X5; CA L5N 2X5
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6156845
• MDR Text Key: 61855004
• Report Number: 8020392-2016-00003
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K050250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

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 Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 32 YR