MAUDE Adverse Event Report: PT. CIBA VISION BATAM FOCUS NIGHT & DAY; EXTENDED WEAR SOFT CONTACT LENS

Catalog Number CBV92000103

Device Problem Microbial Contamination of Device (2303)

Patient Problems Conjunctivitis (1784); Corneal Scar (1793); Corneal Ulcer (1796); Neovascularization (1978); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Corneal Infiltrates (2231); Excessive Tear Production (2235); Eye Pain (4467)

Event Type  Injury  

Event Description

As initially reported by healthcare professional, 30-year-old male patient developed sudden onset of right-eye pain, blurriness, redness, and tearing.Four days after his symptoms started, he went to an outside physician who started him on topical moxifloxacin three times a day, his symptoms were resolved and he resumed contact lens wear.One day later he developed severe bilateral eye pain and was referred to other healthcare professional and reported bilateral photophobia, pain, tearing, and redness.After several examinations his best corrected visual acuity with spectacles was 20/30 in the right eye and 20/50 in the left eye.Anterior segment examination showed 3 conjunctival injections in both eyes with extensive 360 degree corneal vascularization extending 2 mm anterior to the limbus.The right cornea had a small peripheral epithelial defect (0.4 mm diameter) with no evidence of stromal infiltration.The left eye had approximately five circular epithelial defects arranged in a curvilinear pattern across the cornea ranging in diameter from 0.1 to 2.1 mm with surrounding infiltrates.Corneal scrapings, obtained from the left eye, and the consumer¿s contact lenses, contact lens case, and solution were sent for culture.The patient was started on topical natamycin, and moxifloxacin was increased every 2 hour in both eyes by the on-call physician.Cultures of the contact lenses, contact lens case without solution, and 2-month-old solution squirted from the bottle grew gram negative colonies that were identified as alcaligenes xylosoxidans.The corneal scraping cultures were negative.Moxifloxacin was discontinued due to sensitivity and the consumer started on polymyxin b or trimethoprim every hour.Consumer reported improvement of his pain, redness, and photophobia after two days of initial presentation.After one week, natamycin was discontinued and the trimethoprim was tapered to every four hour for five days then four times a day for ten days.Anterior examination showed resolution of the epithelial defects and stromal infiltrates with a residual peripheral stromal scar in the left eye.The current status of consumer¿s eyes was resolved and his best corrected visual acuity with spectacles was 20/25 in both the eyes.No further information can be obtained as this is a case report from literature review.

Manufacturer Narrative

H.3., h.6.: the complaint sample has not returned 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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review and similar complaint review was not performed as lot number was not provided.The manufacturing device history record review was performed prior to product release that the product was manufactured in compliance with the sop.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: FOCUS NIGHT & DAY
• Type of Device: EXTENDED WEAR SOFT CONTACT LENS
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17078013
• MDR Text Key: 316801389
• Report Number: 9681121-2023-00008
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV92000103
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OFPM-MPDS
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male