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

Lot Number 31279047

Device Problem Scratched Material (3020)

Patient Problems Erosion (1750); Corneal Abrasion (1789); Hyperemia (1904)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Remedial action changed to n/a from other in the previously submitted regulatory report/s.

Manufacturer Narrative

Remedial action changed to n/a from other in the previously submitted regulatory report/s. The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Sample received opened in a flat pack 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. Patient code (labeled) - eye disease. The manufacturer internal reference number is: (b)(4).

Event Description

On (b)(6) 2017, as initially reported, a female patient experienced contact lens issue two days after contact lens wear. She was diagnosed with an eye disease and had to undergo therapy after a specialist examination performed by an ophthalmologist. The ecp stated that the contact lens was blurry and it had a scratch that scratched the cornea. After the examination, the consumer stopped wearing contact lenses and continued with the unspecified therapy. On (b)(6) 2017, additional information was received. The patient was diagnosed with corneal erosion on her right eye (od). She was prescribed with tobramycin drops, twice a day for eight days and bepanthol eye drops, three times a day. The patient completely recovered after eight days. On (b)(6) 2017, additional information was received. The patient reported that the contact lens was not blurry prior to wearing. The physician found the contact lens blurry during examination, when lens was in the eye. Additional information was received on (b)(6) 2017. It was reported that the eye joint had a mild hyperemia and there was round erosion with a size of 1. 5 x 1. 5 mm in the projection of the pupil edge at six hours of the eye cornea. It was added that it was intensely stained with fluorescein.

• Brand Name: AIR OPTIX NIGHT & DAY 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
• MDR Report Key: 7145333
• MDR Text Key: 119242775
• Report Number: 9681121-2017-00078
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2022
• Device Lot Number: 31279047
• Other Device ID Number: 000000000010043899-155700001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/09/2018

Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data

Date Received: 12/25/2017 Patient Sequence Number: 1