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

Catalog Number CBV92027782

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Irritation (1941); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not 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

It was initially reported by a distributor via email on (b)(6) 2018 that a female consumer had an eye infection in her left eye after wearing the contact lenses.She threw away the lenses she was wearing, the case and solution.After the infection cleared up, she wore the lenses and got another eye infection in her left eye.Her ecp diagnosed a corneal ulcer of the left eye.New information obtained from the consumer via phone follow-up on 30mar2018 stated that she did not remember the exact date of event.Upon putting the first contact lens in her left eye, she experienced redness and irritation within an hour of wear.The consumer removed the contact lens and went to see her ecp who informed her that she had a bacterial infection which was a result of wearing the contact lens.She threw out the contact lens and wore glasses until her symptoms resolved.At that point, she tried to wear another contact lens for the left eye from the same box and within hours experienced redness and irritation.She removed the contact lens and went again to see her ecp who diagnosed her with corneal ulcer.The consumer was prescribed besifloxacin %0.6 with an unspecified treatment modality.Her symptoms have completely resolved and she was wearing glasses.Additional information has been requested but not yet received.

Manufacturer Narrative

This is the first of two reports for the same patient involving two lot numbers of the same product.It is unknown which contributed to the event.Refer to (b)(4) for the reported lot number 10292800.The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.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.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX COLORS
• 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: 7436568
• MDR Text Key: 105716946
• Report Number: 3006186389-2018-00013
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K133176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CBV92027782
• Device Lot Number: 10309654
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other