MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX UNSPECIFIED; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00094

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Discomfort (2330)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

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.This is the first of two reports for the same patient involving two unidentified lot numbers of the same product.It is unknown which contributed to the event.Refer to 2018-66222-01 for the first reported unidentified lot number.The manufacturer internal reference number is: (b)(4).

Event Description

It was initially reported on (b)(6) 2018 via website that the consumer experienced discomfort and corneal abscess on the right eye.It was reported that 15 days after receiving the new lenses the right eye began to ¿annoy¿ the consumer.The consumer changed lenses and after one or two days the consumer experienced discomfort.The consumer changed lenses and after a week it was impossible to keep the lenses on the eye.The consumer experienced abscess on the cornea.The consumer was treated for five weeks with regular visits to the hospital to monitor the evolution of the abscess.Additional information has been requested but not yet received.

Manufacturer Narrative

New patient codes added.This is the first of two reports for the same patient involving two unidentified lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the second reported unidentified lot number.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received on 24sep2018 stating that the consumer felt itching and swelling of the eyelid after two days along with the previously reported discomfort.It was also stated that the consumer was on tobramycin/ciloxan/desomedine antibiotic eye drops and was advised to use ophthalmic solutions every hour then every two hours then every four hours to finish at three times a day and 1 at night for the first 14 days.The consumer was also advised not to wear monthly contact lenses.Additional information has been requested but not yet received.

Manufacturer Narrative

This is the first of two reports for the same consumer involving two unidentified lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the second reported unidentified lot number.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX UNSPECIFIED
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• MDR Report Key: 7896913
• MDR Text Key: 120965003
• Report Number: 3006186389-2018-00029
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00094
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTI-FREE PUREMOIST; OPTI-FREE PUREMOIST
• Patient Outcome(s): Other