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

Lot Number 10279307

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Sensation in Eye (1869); Irritation (1941); Pain (1994); Red Eye(s) (2038); Swelling (2091); Blurred Vision (2137); Visual Disturbances (2140); Discomfort (2330)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

As initially reported by an optician via telephone on (b)(6) 2017.A female patient reported irritation, ¿emergencies signaled mechanical erosion¿ in the right eye (od) after placing the contact lenses.The reporter also stated that there was ¿amoebic cover¿ (no specifications about the amoebic cover were provided at the time of this report).Patient¿s eye status was not known at the time of this report.Additional information was received on 05/30/2017 via a questionnaire completed by the optician and a medical report of the emergencies; medical report from emergency room stated: mechanical erosion lower than 1 mm of the right cornea along with ¿amoeba cover¿ upon placement of contact lenses.No abscess was observed and the consumer was asked to stop contact lens wear temporarily.It was noted in the questionnaire that the (b)(6) consumer who is a contact lens user for 20 years experienced physical discomfort, sensation of needles behind the eye, visual discomfort/blurred vision, irritation, severe eye redness and severe pain in the right eye immediately upon the first usage of the contact lens on (b)(6) 2017.Patient was treated with unspecified antibiotic ointment, eye drops and lubricant (with unspecified modality) and corrective measures for photosensitivity along with temporary discontinuation of contact lens wear.The event was reported as resolved with persisting swollen eyes, physical discomfort and temporary scar (location not specified).It was also reported that the consumer resumed contact lens wear without any problem.Additional information has been requested but not yet received.

Manufacturer Narrative

The complaint sample has 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

Additional information was received from the initial reporter on 06/28/2017.The consumer was still experiencing photophobia and swollen eyes.It was reported that the consumer could only tolerate contact lens wear for a short duration of time.The consumer was prescribed tobramycin opthalmic ointment, desomedine eye drops and an unspecified ocular lubricant.Additional information has been requested but not yet received.

Manufacturer Narrative

The complaint product was returned for evaluation 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.(b)(4).

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE
• 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
• Manufacturer (Section G): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6642004
• MDR Text Key: 77606098
• Report Number: 3006186389-2017-00053
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Lot Number: 10279307
• Other Device ID Number: 000000000010109115-701488364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR