MAUDE Adverse Event Report: CIBA VISION GMBH DAILIES TOTAL 1 LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92004051

Device Problems Contamination (1120); Patient-Device Incompatibility (2682)

Patient Problems Corneal Edema (1791); Acanthameba Keratitis (1945); Red Eye(s) (2038); Increased Sensitivity (2065); Excessive Tear Production (2235); Discomfort (2330)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). The complaint sample has been returned for evaluation. 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. (b)(4).

Event Description

As initially reported by an ophthalmologist through telephone on (b)(6) 2018, the ecp stated that a diagnosis of keratitis was confirmed on a female consumer. Received additional information on 01jun2018 confirming that the affected eye was the right eye and all symptoms are still experienced. It was established that the consumer reported experiencing discomfort. The patient was hospitalized from (b)(6) 2018 and was diagnosed with acanthamoeba keratitis. Received additional information on 13jun2018 stating that the consumer reported to have initially felt irritation on the morning of (b)(6) 2018, the consumer added to have experienced a sense of photophobia and lacrimation. She then visited an ecp on (b)(6) 2018 and was prescribed with levofloxacin and sodium hyaluronate eye drops with unknown treatment modality. Moreover, the consumer also detailed that she had visited another clinic (b)(6) 2018 and was suspected to have corneal herpes, she then had the following treatment regimen prescribed, acyclovir tablets to be given five (5) times per day from (b)(6) 2018, vancomycin eye drops to be given three (3) times per day from (b)(6) 2018, acyclovir ophthalmic ointment to be given three (3) times per day, and loxoprofen tablets with unknown treatment modality. The consumer further reported that she was also referred to a hospital on (b)(6) 2018 where she was admitted for an unspecified case-related emergency, where she underwent the following treatment course, right vision (rv)
=
not done/10 cm; cefepime hydrochloride to be given two (2) times per day; levofloxacin hemihydrate to be given every hour; tobramycin to be given every hour; ofloxacin ophthalmic ointment to be given before sleep and rebamipide to be given three (3) times per day. On (b)(6) 2018, the consumer was additionally prescribed with voriconazole to be given six (6) times a day and atropine to be given once a day. Also, a sample was taken for corneal epithelial culture which yielded negative result last may (b)(6) 2018. On (b)(6) 2018, the consumer was prescribed stericlon to be given every hour. Following that, cefepime hydrochloride was discontinued on (b)(6) 2018. Another corneal epithelial culture was done on (b)(6) 2018 which resulted to positive acanthamoeba. Three days after on (b)(6) 2018, the consumer experienced conjunctival redness which was alleviated, ciliary hyperemia, ulcer which was confirmed at the center of the cornea, corneal edema and corneal stroma opacity. Keratic precipitates (kps) were then reported to have resolved and negative hypopyon confirmed. Furthermore, right vision (rv)
=
0. 01 was noted and the patient went through the following treatment regimen, levofloxacin hemihydrate and tobramycin were discontinued, gatifloxacin ophthalmic solution to be given four (4) times per day, fluconazole ophthalmic solution to be given six (6) times per day and fluconazole internal medicine were additionally prescribed. The patient also had corneal scraping and was later discharged from the hospital. As of (b)(6) 2018, the consumer was prescribed the following medications: stericlon ophthalmic solution to be given every hour, atropine to be given once a day, gatifloxacin to be given six (6) times per day, voriconazole to be given six (6) times per day, fluconazole to be given six (6) times per day and fluconazole internal medicine to be given once a day. Symptom has alleviated. Received additional information on 15jun2018 clarifying the event date which was on (b)(6) 2018 and the complete name of the consumer. In addition to that, additional information was received on 13jun2018 through email stating that the turbidity of the consumer¿s lacrimation in her right eye has aggravated slightly due to the immune response; however, the transparency of the vicinity of the area is alleviating. Thus, the treatment seems to be working. Received additional information on (b)(6) 2018 stating that the consumer revisited the clinic on (b)(6) 2018 and was instructed to continue using the prescribed eye drops. Additional information has been requested but not yet received.

• Brand Name: DAILIES TOTAL 1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer (Section G): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7640681
• MDR Text Key: 112430929
• Report Number: 9610813-2018-00009
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CBV92004051
• Device Lot Number: N1152740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 06/27/2018 Patient Sequence Number: 1