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

Catalog Number CBV92027782

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

Patient Problems Eye Injury (1845); Ulcer (2274); Discomfort (2330)

Event Date 02/20/2018

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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported via telephone on (b)(6) 2018, a female consumer experienced a lot of discomfort after four hours of initial use which made her decide to seek medical help and visited the hospital.It was then made known that a wound on her eye and an unspecified ulcer on the other eye was seen upon examination.Medical treatment, laboratory tests and current eye condition was not disclosed.As of 26feb2018, additional details are being requested but not yet received.Further details received on 27feb2018 confirming that the suspected products were discarded and is unavailable for return.Additional data has been requested for samples of the same lot.Additional data was received on 05mar2018.The optician sent an email on (b)(6) 2018 confirming that the consumer is getting better.Medical records and other important details shall be sent within the week.As of 15mar2018, follow-up attempts were unsuccessful confirming that the consumer is unwilling and unable to follow up.Further data such as patient resolution and sample availability were unavailable.

Manufacturer Narrative

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).

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.Patient code 3191 - reactive follicles.The result code 3233 and conclusion code 20 was not accurately entered on the mdr which was submitted on 03/23/2018.This smdr (follow-up 1) is being submitted to indicate that this entry should have reflected result code 3221 and conclusion code 67.Additional conclusion code 92 was also included to capture device not returned.The manufacturer internal reference number is: (b)(4).

Event Description

As of 19may2018, further details were provided by the physician which confirmed that the consumer came to visit.The physician noted that the consumer had been discharged and had resumed contact lens wear but it was on pending revision since she does not see well on distant view.In the attached medical discharge report, it was stated that the consumer tried a new set of contact lens and experienced irritation in her eyes.It was confirmed that the consumer had central superficial corneal ulcer on her left eye.Part of her discharge treatment plan were ocular medications such as, tobramycin antibiotic eye drops administered every four hours, ciprofloxacin antibiotic ointment applied every six hours, artificial tears and ophthalmic wipes.The consumer's current eye condition remains unknown.Additional information has been requested but has not been received.As of 25may2018, further details from the optician confirmed that the event had taken place on (b)(6) 2018, the first day the consumer bought the contact lenses.The optician added that the consumer was discharged after three weeks and claimed to have had a positive resolution to the event, however the optician did not have the opportunity to do an eye assessment.The optician noted that both eyes were doing good as the consumer resumed contact lens wear.The location of the corneal ulcer was not determined but was said to have resolved after treatment.Other medical information such as laboratory tests and follow up visits were not disclosed.No other data can be obtained.

• 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: 7365124
• MDR Text Key: 103286862
• Report Number: 3006186389-2018-00008
• 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: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 10309096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other