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

Lot Number 31160284

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Foreign Body Sensation in Eye (1869); Unspecified Infection (1930); Itching Sensation (1943); Ulcer (2274); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports for the same patient involving two complaint product lot numbers; this report represents lot number 31160284. The complaint product has not 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 a patient, she felt ongoing discomfort with contact lens wear starting in (b)(6) 2016. In (b)(6) 2016, the patient experienced eye redness and itching. The patient sought medical attention with three different eye care providers (ecp). The patient was diagnosed with "small ulcers in the eye" and resumed contact lens wear after the ecp stated that her eyes were "cured. " the patient experienced ongoing itchiness after resuming contact lens wear, for which she was treated for an infection; the patient was advised to discontinue contact lens wear for three days during this time. Upon resuming contact lens wear in (b)(6), the patient experienced similar symptoms, inclusive of foreign body sensation. At that time, her ecp advised her to discontinue use of the complaint product, suggesting that the symptoms could be attributed to a lack of oxygenation from contact lens wear. The events have resolved, with patient not wearing contact lenses. Further information received from the patient clarified that the following medications were prescribed: anti-inflammatory eye drops, antibiotic eye drops, and a steroid eye drop (the dosages and treatment dates of the medications were not specified). Additional information has been requested but not received.

Manufacturer Narrative

This is the first of two reports for the same patient involving two complaint product lot numbers; this report represents lot number 31160284. The actual complaint product was not returned for evaluation. A trend related investigation was performed; no trend could be identified. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint. The root cause could not be determined. (b)(4).

Manufacturer Narrative

This is the first of two reports for the same patient involving two complaint product lot numbers; this report represents lot number 31160284. Unopened samples from this reported complaint lot were returned for evaluation and were 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. The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6230331
• Report Number: 9681121-2017-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2020
• Device Lot Number: 31160284
• Other Device ID Number: 000000000010035961-155670800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Age: 34 YR
• Patient Outcome(s): Other