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

Lot Number 10321345

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Laceration(s) (1946)

Event Date 07/21/2017

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

As initially reported, 07/21/2017, a call was received from consumer stated that two contact lenses were found in one blister pack, resulting in having two contact lenses stuck in her eyes.She consulted an eye care provider and reported that an ulcer/laceration was seen in the right eye.She used unspecified drops every hour.The consumer was scheduled to follow-up with her eye care provider later that day.Symptoms were not yet resolved.Further information received stated that the consumer did not continue follow-up with her eye care provider as scheduled.Consumer stated that she cancelled her visit to ecp.Symptoms resolved, she has not resumed contact lens wear and she stated that she would not be resuming contact lens wear.She will be in glasses.Further information was received from the consumer via faxed medical and billing records, and are summarized as follows: the consumer was seen by an emergency eye care provider (ecp) on (b)(6) 2017.Fluorescein staining was performed during this visit, and it was also reported that a topical anesthetic was used as well.The consumer was discharged on moxifloxacin opthalmaologic solution 0.5% to use one drop in the right eye, every hour on the hour.The consumer was advised to return for follow-up the next day; however, a note was made that this follow-up appointment was cancelled.Additional information was received from the consumer via a faxed prescription profile.It was reported that the consumer obtained ofloxacin opthalmaologic solution 0.3% on (b)(6) 2017.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.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.(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: 6801904
• MDR Text Key: 82958418
• Report Number: 3006186389-2017-00075
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Lot Number: 10321345
• Other Device ID Number: 000000000010109085-701488364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: METFORMIN - DATES UNK
• Patient Outcome(s): Other
• Patient Age: 49 YR