MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Discomfort (2330)

Event Type  Injury  

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

As initially reported by an optician on 03/01/2017, a consumer introduced the contact lens into the left eye (os) and immediately felt discomfort.The consumer persisted using the lens during the week and developed an unspecified ocular infection.At this point, the consumer went to an ophthalmologist (ecp) where she was diagnosed with a corneal lesion; however, the ophthalmologist did not associate the event to contact lens wear due to the consumer not reporting the fact that she wore contact lenses to the ecp.After using an unspecified treatment modality, the consumer attempted to resume contact lens wear and continued to experience discomfort bilaterally.Additional information received on 03/20/2017 from the initial reporter stated that the consumer experienced discomfort when the contact lens was first placed upon the os, continuing to wear the contact lens until the discomfort started to worsen.The consumer attempted to wear the same lens upon the right eye (od), but experienced pinching, therefore the contact lens was immediately removed.The consumer was prescribed dexamethasone sodium phosphate/gentamicin sulfate ointment to use at night and hypromellose/dexpanthenol solution every one hour for ten days.The consumer reported that her eye care provider indicated that there was no sequelae from the event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.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.Correction: in the previously submitted smdr (file id (b)(4)), a correction to the field event date was reported in error.Instead, the correction was made to the (gender of the patient).(b)(4).

Manufacturer Narrative

Updated fields of mdr describe event or problem, date rec¿d by mfr and event problem and evaluation codes.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by an optician on 03/01/2017, a consumer introduced the contact lens into the left eye (os) and immediately felt discomfort.The consumer persisted using the lens during the week and developed an unspecified ocular infection.At this point, the consumer went to an ophthalmologist (ecp) where she was diagnosed with a corneal lesion; however, the ophthalmologist did not associate the event to contact lens wear due to the consumer not reporting the fact that she wore contact lenses to the ecp.After using an unspecified treatment modality, the consumer attempted to resume contact lens wear and continued to experience discomfort bilaterally.Additional information received on 03/20/2017 from the initial reporter stated that the consumer experienced discomfort when the contact lens was first placed upon the os, continuing to wear the contact lens until the discomfort started to worsen.The consumer attempted to wear the same lens upon the right eye (od), but experienced pinching, therefore the contact lens was immediately removed.The consumer was prescribed dexamethasone sodium phosphate/gentamicin sulfate ointment to use at night and hypromellose/dexpanthenol solution every one hour for ten days.The consumer reported that her eye care provider indicated that there was no sequelae from the event.Additional information received on 09/04/2017 from the initial reporter stated that it was not the physician but the consumer who associated the adverse events with the contact lenses.The consumer claimed that she always used the lenses properly, cleansed them with peroxide and bought a new package every six months.The consumer also found some deposits in the lens.

• Brand Name: AIR OPTIX AQUA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6443258
• MDR Text Key: 71162105
• Report Number: 9681121-2017-00016
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Other Device ID Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other