MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; EXTENDED WEAR SOFT CONTACT LENS

Catalog Number 000000000010124212

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Scar (1793); Dry Eye(s) (1814); Eye Injury (1845); Intraocular Pressure Increased (1937); Keratitis (1944); Visual Impairment (2138); Eye Pain (4467)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: 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.The manufacturer internal reference number is: (b)(4).

Event Description

As per follow up information received, the consumer experienced irritation and had also previous corneal injury, due to which the store advised her to refrain from wearing lenses for the time being, after two weeks, she decided to try a different product, subsequently after two three days of contact lens wearing the complaints resurfaced, and consumer visited emergency room.The physician diagnosed that both eyes are damaged by lenses, the injury had worsened, after wearing contact lenses again for four hours and then consumer took them out as she experienced right eye (od) blurry, which consumer has described she almost see nothing.The physician concluded severe keratitis od due to contact lenses.Consumer experienced pain behind the eyes.Eye pressure was reported as 30, along with that lab test suggested average tension with increased pachymetry.The complaints have been going on for a month now.The consumer was prescribed with ocular lubricant, hypromellose six times in a day on both eyes (ods) tobramycin/dexamethasone three times a day, ofloxacin ointment three times a day in od.Advice was given not to fly with high eye pressure and to refrain from wearing lenses for at least 1 week.Consumer was asked to return back after two weeks, physician concluded that contact lens overwear on right eye was more than left eye, consumer has dryness of the conjunctiva on both eyes (sicca), and severe keratitis on right eye due to soft monthly lenses, now no activity, only thin scars.The customer was asked to discontinue ofloxacin ointment od, and continue with ocular lubricant on both eyes, and hypromellose six times in a day on both eyes.In case of deterioration, red eye, white dot on cornea or further loss of vision returns for further evaluation.Advice not to wear lenses this week, afterwards wear glasses frequently and are advised not to wear monthly lenses but to wear daily lenses for as short a period as possible (for example only during working hours).In the first period, wear lenses for one day and not for one day.At the time of report symptoms are continuing.Additional information has been requested but not yet available.

• Brand Name: AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM
• Type of Device: EXTENDED WEAR SOFT CONTACT LENS
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18904504
• MDR Text Key: 337671923
• Report Number: 3006186389-2024-00009
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010124212
• Device Lot Number: 10631399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AQUA BALANCE.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female